Panels › Clinical Chemistry › Product code JJY · Class 1
Multi-Analyte Controls, All Kinds (Assayed)
Regulation 862.1660
0510(k)s in 12 months (673 all time)
2recalls in 12 months (95 all time)
73recalls that name a 510(k)
Top companies in JJY
| Company | 510(k)s | Recalls |
|---|---|---|
| Bio-Rad | 61 | 0 |
| Randox Laboratories Limited | 15 | 31 |
| Medical Analysis Systems, Inc. | 31 | 0 |
| Bio-Rad Laboratories | 26 | 1 |
| Roche Diagnostics | 22 | 4 |
| Cliniqa Corporation | 22 | 0 |
| Aalto Scientific, Ltd. | 19 | 0 |
| Maine Standards Co. | 19 | 0 |
| Boehringer Mannheim Corp. | 17 | 0 |
| Casco Standards | 15 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2018 | Randox Laboratories Ltd. Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682 Terminated |
JJY | K972608 |
| Jun 8, 2018 | Randox Laboratories Ltd. Liquid Cardiac Control - Level 3, cat. no. CQ5053
Product Usage:
This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay Terminated |
JJY | K110534 |
| Mar 5, 2018 | Tosoh Bioscience Inc Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418
The product is intended for In Vitro Diagnostic Use Only for performing quality control procedures with the HbA1c Assay. Terminated |
JJY | None listed |
| Aug 11, 2017 | Randox Laboratories Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages) Terminated |
JJY | K140522 |
| Aug 11, 2017 | Randox Laboratories Immunoassay Premium Controls (3x4x5mL and 12x5mL packages) Terminated |
JJY | K140522 |
| Aug 8, 2017 | Randox Laboratories, Limited Liquid Cardiac Control CQ5053 Terminated |
JJY | K110534 |
| Jul 10, 2017 | Ortho Clinical Diagnostics Inc VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Us Terminated |
JJY | K042006 |
| May 31, 2017 | Roche Diagnostics Corporation Elecsys PreciControl Varia 3 Terminated |
JJY | K111506 |
| May 26, 2017 | Randox Laboratories Liquid Urine Control Level 3
For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems. Terminated |
JJY | K110904 |
| May 20, 2017 | Medtest Holdings, Inc. Pointe Scientific Chemistry Controls Level I and II
LEVl: Amber glass vial w/PP white plastic cap.
LEV2: Amber glass vial w/PP black plastic cap. Terminated |
JJY | None listed |
| 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 |
| Oct 14, 2016 | Helena Laboratories, Inc. Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL Terminated |
JJY | K821982 |
| Oct 7, 2016 | Siemens Healthcare Diagnostics, Inc. Advia Chemistry Calibrator
For in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the following methods: Albumin (ALB, ALB_c), Direct Bilirubin (DBIL_2), Total Bilirubin (TBIL_ Terminated |
JJY | K050374 |
| Sep 16, 2016 | Randox Laboratories The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T Terminated |
JJY | K110534 |
| 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 |
| Sep 15, 2015 | MedtestDx, Inc. MedTest DX Control Reconstitution Fluid
Kit configuration: 20 x 5 ml.
Bottle: 5 ml amber glass
Cap: 18 mm white seal plug seal rubber
HC-DIL (Human Control Diluent) is reagent grade water filled in Terminated |
JJY | K942458 |
| Dec 4, 2014 | Microgenics Corporation MAS CardioImmune XL Cardiac Marker Control;
Model: CAI-XL1;
intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determin Terminated |
JJY | K061196 |
| Nov 13, 2014 | Siemens Healthcare Diagnostics, Inc. IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi)
For in vitro diagnostic use with IMMULITE Systems Analyzers for the quantitative measurement of calcito Terminated |
JJY | K023304 |
| Oct 23, 2014 | Medtest Holdings, Inc. MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200)
HEC200
" Sml amber glass vial with rubber stopper and black plastic screw cap.
" 1 0 control vials per box, 12 ce Terminated |
JJY | K942458 |
| Jun 26, 2014 | Microgenics Corporation MAS Omni Immune PRO Controls Terminated |
JJY | K110616 |
| Jun 26, 2014 | Microgenics Corporation MAS Omni Immune Controls Terminated |
JJY | K110616 |
| Feb 3, 2014 | Horiba Instruments, Inc dba Horiba Medical ABX PENTRA Urine Control L/H.
The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control
consisting of liquid solutions prepared from human urine with chemical additives and
mater Terminated |
JJY | K110137 K110530 |
| Jan 31, 2014 | Horiba Instruments, Inc dba Horiba Medical ABX PENTRA N Control, Model No. A11A01653
The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex. Terminated |
JJY | K052007 |
| May 16, 2013 | Bio-rad Laboratories, Inc. Liquichek" ToRCH Plus IgM Control - Positive
Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for t Terminated |
JJY | K040822 |
| 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 |
| Nov 19, 2012 | Microgenics Corporation Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO;
Liquid Assayed Integrated Immunoassay Control.
Intended for use as an assayed control for monitoring assay conditions in many clinical laborator Terminated |
JJY | K110616 |
| Jan 11, 2012 | Microgenics Corporation ThermoFisher Scientific / Microgenics brand MAS CardioImmune XL, Liquid Assayed Cardiac Marker Control, in vitro diagnostic.
Catalog Numbers & Description:
CAI-XLL, Level L; CAI-XL1, Level 1; CAI-X Terminated |
JJY | K061196 |
| Feb 2, 2011 | Abbott Point of Care Inc. i-STAT Level 2 Control Value Assignment Sheets
Human Consumption Terminated |
JJY | None listed |
| Nov 22, 2010 | Biosite Inc Dba Innovacon Inc. Cholestech LDX Calibration Verification, Levels 1-4, Catalog Number 11-255.
To be used for verifying the reportable range of tests on the Cholestech LDX System. Terminated |
JJY | K913687 |
| Nov 22, 2010 | Biosite Inc Dba Innovacon Inc. Cholestech LDX Lipid Controls, Level 1 & 2, 3 vial set, Catalog Number 10-983.
Assayed quality control material for use with the Cholestech LDX System. Terminated |
JJY | K913687 |
| Nov 22, 2010 | Biosite Inc Dba Innovacon Inc. Cholestech LDX Lipid Controls, Level 1 & 2, 1 vial set, Catalog Number 10-982.
Assayed quality control material for use with the Cholestech LDX System. Terminated |
JJY | K913687 |
| Nov 22, 2010 | Biosite Inc Dba Innovacon Inc. Cholestech LDX Multi-Analyte Controls, Level 1 & 2, 3 vial set, Catalog Number 12-713.
Assayed quality control material for use with the Cholestech LDX System. Terminated |
JJY | K913687 |
| Nov 22, 2010 | Biosite Inc Dba Innovacon Inc. Cholestech LDX Multi-Analyte Controls, Level 1 & 2, 1 vial set, Catalog Number 12-712.
Assayed quality control material for use with the Cholestech LDX System. Terminated |
JJY | K913687 |
| Jun 11, 2010 | Biosite Inc Triage Total Controls Calibration Verification 5: Two - 0.25 mL tubes for each of five different levels (A,B,C,D,E). Storage Temp <-20C.
Intended use: Materials used with the Triage Profiler S.O. Terminated |
JJY | K072892 |
| Jun 11, 2010 | Biosite Inc Triage Total Controls 5, Level 2: Five 0.25 mL tubes. Storage Temp <-20C.
Intended use: Assayed materials used with the Triage Profiler S.O.B. Panel, Triage CardioProfilER Panel, Triage BNP Test, Terminated |
JJY | K072892 |
| Jun 11, 2010 | Biosite Inc Triage Total Controls 5, Level 1: Five 0.25 mL tubes. Storage Temp <-20C.
Intended use: Assayed materials used with the Triage Profiler S.O.B. Panel, Triage CardioProfilER Panel, Triage BNP Tes Terminated |
JJY | K072892 |
| Apr 6, 2010 | Vital Diagnostics, Inc. ATAC Serum Control Kit.
The device is used for monitoring the performance of clinical chemistry methods within the clinical range. Terminated |
JJY | K040273 |
| Apr 6, 2010 | Vital Diagnostics, Inc. Envoy 500 Serum Control Kit.
The device is used for monitoring the performance of clinical chemistry methods within the clinical range. Terminated |
JJY | K040273 |
| Jan 17, 2009 | Quantimetrix Corporation Quantimetrix SpinalScopics Spinal Fluid Cell Count Control.
Spinalscopics is a plastic bottle liquid spinal fluid cell count control. This product is intended for monitoring cell counts in patient c Terminated |
JJY | K970862 |
| Jan 17, 2009 | Quantimetrix Corporation Quantimetrix QuanTscopics Urine Microscopics Control.
QuanTscopics is a plastic bottle liquid urine microscopic quality control. It is a bi-level control with stabilized human blood cells provide a m Terminated |
JJY | K925256 |
| Mar 4, 2008 | Roche Diagnostics Corp. Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Roche Diagnostics Corporation, Indianapolis, IN 46250. Terminated |
JJY | K060373 |
| Dec 29, 2007 | Roche Diagnostics Corp. Roche Ammonia/Ethanol/CO2 Control A (Abnormal) for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas c111 and cobas 46250 c 501 clinical chemistry analyzers; Cat. Number. 20753009190. Roch Terminated |
JJY | K031880 |
| Dec 29, 2007 | Roche Diagnostics Corp. Roche Ammonia/Ethanol/CO2 Control N (Normal) for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas c111 and cobas c 501 clinical chemistry analyzers; Catalog. No. 20752401190. Roche Diagnos Terminated |
JJY | K031880 |
| Jul 20, 2004 | Beckman Coulter Inc Synchron Systems Hemoglobin A1c (HbA1c) Reagent Terminated |
JJY | K974452 |
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