ClearanceBrief
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

CodeDeviceRecords
GJSTest, Time, Prothrombin14
KTNSystem, Test, Infectious Mononucleosis8
JHIVisual, Pregnancy Hcg, Prescription Use6
NBCTest, Natriuretic Peptide5
CGAGlucose Oxidase, Glucose4
DKZEnzyme Immunoassay, Amphetamine4
JJYMulti-Analyte Controls, All Kinds (Assayed)4
DJREnzyme Immunoassay, Methadone3
GHHFibrin Split Products2
GTYAntigens, All Groups, Streptococcus Spp.2
MMIImmunoassay Method, Troponin Subunit2
CHHEnzymatic Esterase--Oxidase, Cholesterol1
CKDHydrazone Colorimetry, Alt/Sgpt1
DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control1
DCKC-Reactive Protein, Antigen, Antiserum, And Control1
DIFDrug Mixture Control Materials1
DISEnzyme Immunoassay, Barbiturate1
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use1
LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl1
LDPColorimetry, Acetaminophen1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Sep 20, 2023K223179Cholestech LDX ™ System
Alere San Diego, Inc.
CGA
Aug 12, 2015K151935Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori W
Alere San Diego, Incorporated
LYR

Latest recalls

DateFirm and productCodeLinked 510(k)
Sep 25, 2026Alere 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
JHIK993317
Sep 25, 2026Alere 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
JHIK993203
Sep 25, 2026Alere 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
JHIK993065
Sep 25, 2026Alere 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
JHIK062361
Apr 30, 2024Alere San Diego, Inc.
Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
Open, Classified
CGAK120615
Jun 24, 2022Alere 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
CGAK120615
Feb 15, 2019Alere 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
JJEK120615
Nov 14, 2017Alere 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
DKZK973784
Nov 16, 2016Alere 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
JJYK072892
Aug 19, 2016Alere 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
GJSK092987
Aug 19, 2016Alere 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
GJSK092987
Aug 19, 2016Alere 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
GJSK072727
Aug 19, 2016Alere 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
GJSK110212
Aug 19, 2016Alere 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
GJSK110212
Aug 19, 2016Alere 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
GJSK072727
Aug 19, 2016Alere 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
GJSK020679
Aug 19, 2016Alere 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
GJSK020679
Aug 19, 2016Alere 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
GJSK110212
Aug 2, 2016Alere 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
LBSK120615
Jun 22, 2016Alere 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
KTNK042272
Jun 22, 2016Alere 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
KTNK042272
Jun 22, 2016Alere 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
KTNK042272
Jun 22, 2016Alere 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
KTNK042272
Jun 22, 2016Alere 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
KTNK042272
Jun 22, 2016Alere 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
KTNK042272
Jun 22, 2016Alere 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
KTNK042272
Oct 15, 2015Alere 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
JJYK102700
Jan 3, 2015Alere 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
GJSK072727
K092987 +1
Jan 3, 2015Alere 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
GJSK020679
K021923 +1
Jan 3, 2015Alere 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
GJSK020679
K021923 +3
Jun 26, 2014Alere 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
NBCNone listed
Jun 6, 2014Alere 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
GHHK042890
May 8, 2014Alere 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
GJSK092987
May 2, 2014Alere 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
NBCK052789
Mar 17, 2014Alere 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
DJRK060791
Jan 9, 2014Alere 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
DKZNone listed
Nov 22, 2013Alere 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
CGAK120615
Oct 23, 2013Alere 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
DIFK060788
May 25, 2013Alere 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
JHIK062361
May 21, 2013Alere 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
JHIK993317
Apr 25, 2013Alere 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
DCKK040579
Apr 18, 2013Alere 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
KTNK042272
Apr 17, 2013Alere 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
CKDK032027
K991834
Jan 29, 2013Alere 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
JJYK102700
Jan 29, 2013Alere 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
JJYK102700
Oct 10, 2012Alere 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
DJRK060791
Sep 26, 2012Alere 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
LDPK043242
K060791
Jul 19, 2012Alere 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
DJRK060791
Jul 6, 2012Alere 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
GHHK042890
Jul 6, 2012Alere 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
NBCK051781

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