Company · US
Alere San Diego, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2023. Name variants (Inc, Corp, punctuation) are merged.
2510(k) clearances (0 in 12 months)
63recalls (4 in 12 months)
61recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GJS | Test, Time, Prothrombin | 14 |
| KTN | System, Test, Infectious Mononucleosis | 8 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 6 |
| NBC | Test, Natriuretic Peptide | 5 |
| CGA | Glucose Oxidase, Glucose | 4 |
| DKZ | Enzyme Immunoassay, Amphetamine | 4 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 4 |
| DJR | Enzyme Immunoassay, Methadone | 3 |
| GHH | Fibrin Split Products | 2 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 2 |
| MMI | Immunoassay Method, Troponin Subunit | 2 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CKD | Hydrazone Colorimetry, Alt/Sgpt | 1 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 1 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 |
| DIF | Drug Mixture Control Materials | 1 |
| DIS | Enzyme Immunoassay, Barbiturate | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 |
| LDP | Colorimetry, Acetaminophen | 1 |
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Alere San Diego, Inc. Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526;
Henry Schein, Inc. One Step + Urine Cassette Test, Model/ Part: FHC-102/9004074, FHC-102/9004073;
Alere hCG Cassette (25mIU/mL) in Open, Classified |
JHI | K993317 |
| Sep 25, 2026 | Alere San Diego, Inc. Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527;
McKesson CONSULT hCG Urine Test Dipstick CLIA Waived, Model/ Part:FHC-101/5000;
Henry Schein One Step+ hCG Urine Strip Test, Open, Classified |
JHI | K993203 |
| Sep 25, 2026 | Alere San Diego, Inc. Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528;
Beckman Coulter Inc's ICON 25 hCG, Model/ Part: FHC-202/43025;
Henry Schein One Step+ hCG Combo test in S Open, Classified |
JHI | K993065 |
| Sep 25, 2026 | Alere San Diego, Inc. McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001;
Alere hCG Cassette (20 mIU/mL) in Urine, Model/ Part: FHC-A102/92210;
Fisher Scientific Sure-Vue Serum/UrinehCG-STAT, Model/ Part: FHC- Open, Classified |
JHI | K062361 |
| Apr 30, 2024 | Alere San Diego, Inc. Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170 Open, Classified |
CGA | K120615 |
| Jun 24, 2022 | Alere San Diego, Inc. The Cholestech LDX System combines enzymatic methodology and solidphase
technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples
used for testing can be whole blood Open, Classified |
CGA | K120615 |
| Feb 15, 2019 | Alere San Diego, Inc. Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d - Product Usage: The Alere Cholestech LDX System is a small, portable analyzer and Terminated |
JJE | K120615 |
| Nov 14, 2017 | Alere San Diego, Inc. Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottle of
Wash Solution, 1 Pipette and 50 Pipette Tips in a labeled kit box.
Product Completed |
DKZ | K973784 |
| Nov 16, 2016 | Alere San Diego, Inc. Alere Triage Total 5 Control Level 1, Model No. 88753
Description of the product: The Triage Total Controls 5 are quality control materials that are used to assist the laboratory in monitoring test p Terminated |
JJY | K072892 |
| Aug 19, 2016 | Alere San Diego, Inc. Alere INRatio/ INRatio2 PT/INR Test Strips
Model Number: 99007EU, 99007G1, 99007G3, 99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5, 99008G7
Product Usage:
The Alere INRatio/INRatio2 system uses Terminated |
GJS | K092987 |
| Aug 19, 2016 | Alere San Diego, Inc. Alere INRatio PT/INR Test Strips
Model Number: 0100071, 0100139
Product Usage:
The INRatio/INRatio2 Test Strips perform a modified version of the one-stage Prothrombin Time test, using a recombinant Terminated |
GJS | K092987 |
| Aug 19, 2016 | Alere San Diego, Inc. Alere INRatio2 PT/INR Professional Monitoring System
Model Number: 55128A
Product Usage:
The Alere INRatio/INRatio2 system uses a modified version of the one-stage PT test. After a drop of blood is a Terminated |
GJS | K072727 |
| Aug 19, 2016 | Alere San Diego, Inc. Alere INRatio2 Replacement Monitor (Home)
Model Number: 0200457
Product Usage:
Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio 2 PT/INR Home Monitoring System, consisting of the INRa Terminated |
GJS | K110212 |
| Aug 19, 2016 | Alere San Diego, Inc. Alere INRatio2 PT/INR Home Monitoring System
Model Number: 0200432, 0200433
Product Usage:
Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio 2 PT/INR Home Monitoring System, consisting Terminated |
GJS | K110212 |
| Aug 19, 2016 | Alere San Diego, Inc. Alere INRatio2 PT/INR Professional Testing System
Model Number: 0200431
Product Usage:
The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, c Terminated |
GJS | K072727 |
| Aug 19, 2016 | Alere San Diego, Inc. Alere INRatio Replacement Monitor
Model Number: 0100137
Usage:
The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. T Terminated |
GJS | K020679 |
| Aug 19, 2016 | Alere San Diego, Inc. INRatio Prothrombin Time (PT) Monitoring System
Model Number: 0100007
Product Usage:
The INRatio Prothrombin Time Monitoring System uses a modified version of the one-stage PT test. After a drop of Terminated |
GJS | K020679 |
| Aug 19, 2016 | Alere San Diego, Inc. Alere INRatio PT/INR System Professional
Model Numbers: 0100004
Product Usage:
Alere INRatio 2 PT/INR Monitoring System (Professional Use): The Alere INRatio 2 PT/INR Monitoring System (Professiona Terminated |
GJS | K110212 |
| Aug 2, 2016 | Alere San Diego, Inc. LDX Optical Check Cassettes (OCC)
Model Number: 10-228 and 14-535
Cassette in box with foam insert. The cassette is used to check the optics system of the LDX analyzer.
Product Usage:
The Optics Che Terminated |
LBS | K120615 |
| Jun 22, 2016 | Alere San Diego, Inc. Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25
a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whol Terminated |
KTN | K042272 |
| Jun 22, 2016 | Alere San Diego, Inc. Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L
a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in wh Terminated |
KTN | K042272 |
| Jun 22, 2016 | Alere San Diego, Inc. Proadvantage Mono Rapid Test Cassette, Catalog No. P080016
a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blo Terminated |
KTN | K042272 |
| Jun 22, 2016 | Alere San Diego, Inc. Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in w Terminated |
KTN | K042272 |
| Jun 22, 2016 | Alere San Diego, Inc. Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401
a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole Terminated |
KTN | K042272 |
| Jun 22, 2016 | Alere San Diego, Inc. Cardinal Health Mono Rapid Test, Catalog No. B1077-28,
a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, Terminated |
KTN | K042272 |
| Jun 22, 2016 | Alere San Diego, Inc. Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test Device a simple test that utilizes an extract of bovine erythrocytes to qualitatively and se Terminated |
KTN | K042272 |
| Oct 15, 2015 | Alere San Diego, Inc. Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773.
Enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG) an Terminated |
JJY | K102700 |
| Jan 3, 2015 | Alere San Diego, Inc. INRatio 2 Monitors
- 0200431 Alere INRatio 2 PT/INR Professional Testing System
- 0200432 Alere INRatio 2 PT/INR Home Monitoring System
- 0200433 Alere INRatio 2 PT/INR Home Monitoring System
- 020045 Terminated |
GJS | K072727 K092987 +1 |
| Jan 3, 2015 | Alere San Diego, Inc. INRatio Monitors
- 0100004 Alere INRatio PT/INR System Professional
- 0100007 INRatio Prothrombin Time (PT) Monitoring System
- 0100137 Alere INRatio Replacement Monitor
The test systems contain indi Terminated |
GJS | K020679 K021923 +1 |
| Jan 3, 2015 | Alere San Diego, Inc. Alere INRatio PT/INR Test Strips, Alere INRatio
PT/INR System Professional
- 0100071 Alere INRatio PT/INR Test Strips, Box of 12
- 0100139 Alere INRatio PT/INR Test Strips, Box of 48
The test strips Terminated |
GJS | K020679 K021923 +3 |
| Jun 26, 2014 | Alere San Diego, Inc. Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202
The Alere Triage BNP test is intended for use with the Beckman Coulter Access Family of Immu Terminated |
NBC | None listed |
| Jun 6, 2014 | Alere San Diego, Inc. Alere Triage D-Dimer Test
PN 98100, Lot W53884B.
The Alere Triage D-Dimer Test is a fluorescence immunoassay to be used with the Alere Triage Meters for the quantitative determination of cross-linked Terminated |
GHH | K042890 |
| May 8, 2014 | Alere San Diego, Inc. Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere INRatio2 PT/INR Monitoring System (Professional Use), consisting of the Monitor and test strip, is used for quantitativ Terminated |
GJS | K092987 |
| May 2, 2014 | Alere San Diego, Inc. Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Model Number 98200, Lot Numbers: 329599, 331265. The Alere Triage BNP test is intended to be used as an aid Terminated |
NBC | K052789 |
| Mar 17, 2014 | Alere San Diego, Inc. Product Brand Name(s): Alere Triage TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56035B.
25 individually pouched devices in a labeled kit box.
Indications for use: The Alere Triage T Terminated |
DJR | K060791 |
| Jan 9, 2014 | Alere San Diego, Inc. Product Brand Name(s):
Innovacon Oral Fluid Drug Screen Device,
OrALert Oral Fluid Drug Screen Device,
OrALert Oral Fluid Drug Screen Device with BZO,
Reditest On-Site Oral Fluid Drug Screen Devic Terminated |
DKZ | None listed |
| Nov 22, 2013 | Alere San Diego, Inc. Product Brand Name(s): Alere Cholestech LDX Lipid Profile"GLU Test Cassette, Model 10-991.
Product Generic Name: Alere Cholestech LDX Lipid Profile"GLU Test Cassette.
Description of the product: Lipid Terminated |
CGA | K120615 |
| Oct 23, 2013 | Alere San Diego, Inc. Alere Triage TOX Drug Screen Control 1
Product Generic Name: Quality Control Material
Description of the product:
Good Laboratory Practice suggests that external controls should be tested with each Terminated |
DIF | K060788 |
| May 25, 2013 | Alere San Diego, Inc. Alere" hCG Combo Cassette (20/10 mIU/mL) Kit.
Product Usage: The AlereTM hCG Combo (20/10 mIU/mL) test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonado Terminated |
JHI | K062361 |
| May 21, 2013 | Alere San Diego, Inc. Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026)
The SP hCG Cassette Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human chorio Terminated |
JHI | K993317 |
| Apr 25, 2013 | Alere San Diego, Inc. The Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807.
Product Usage:
Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Ch Terminated |
DCK | K040579 |
| Apr 18, 2013 | Alere San Diego, Inc. IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201
The MONO test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of Infecti Terminated |
KTN | K042272 |
| Apr 17, 2013 | Alere San Diego, Inc. Alere Cholestech LDX ALT AST Test Cassette, Model #12-788.
For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Terminated |
CKD | K032027 K991834 |
| Jan 29, 2013 | Alere San Diego, Inc. Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770
Alere Cholestech LDX Calibration Verification (hereafter referred to as CAL VERS) enables users to monitor the perform Terminated |
JJY | K102700 |
| Jan 29, 2013 | Alere San Diego, Inc. Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769
Alere Cholestech LDX Multianalyte Control (hereafter referred to as Controls) enables users to monitor the performance of Terminated |
JJY | K102700 |
| Oct 10, 2012 | Alere San Diego, Inc. Triage TOX Drug Screen Panel, Model# 94400.
Product Usage:
The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative dete Terminated |
DJR | K060791 |
| Sep 26, 2012 | Alere San Diego, Inc. Alere Triage TOX Drug Screen 9 Panel, P/N: 94402.
The Alere Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Alere Triage Meters for the qualitative determination of Terminated |
LDP | K043242 K060791 |
| Jul 19, 2012 | Alere San Diego, Inc. Alere Triage Tox+MTD Drug Screen, PN 94400
Product Usage:
The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage Meters for the qualitative determination of t Terminated |
DJR | K060791 |
| Jul 6, 2012 | Alere San Diego, Inc. Triage D-dimer PN 98100
Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism. Terminated |
GHH | K042890 |
| Jul 6, 2012 | Alere San Diego, Inc. Alere Triage BNP PN 98000XR
Intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure). Terminated |
NBC | K051781 |
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