JJY · Multi-Analyte Controls, All Kinds (Assayed)
Clinical Chemistry · 21 CFR 862.1660 · Class 1
Overview
| Product Code | JJY |
|---|---|
| Device Name | Multi-Analyte Controls, All Kinds (Assayed) |
| Regulation | 21 CFR 862.1660 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.
Classification Rationale
Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (20 of 673)
Showing 20 most recent of 673 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K162530 | Multichem IA Plus | Techno-Path Manufacturing | Mar 31, 2017 | SESE |
| K163629 | Audit MicroControls Linearity FD Tumor Markers II | Aalto Scientific, Ltd. | Mar 10, 2017 | SESE |
| K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak | Bio-Rad Laboratories | Jan 10, 2017 | SESE |
| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit | Radiometer America, Inc. | Jan 28, 2016 | SESE |
| K150300 | Liquichek Cardiac Markers Plus Control LT | Bio-Rad Laboratories | Dec 11, 2015 | SESE |
| K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test Kit | Maine Standards Company, LLC | Apr 30, 2015 | SESE |
| K143379 | Liquichek Maternal Serum II Control | Bio-Rad Laboratories | Mar 13, 2015 | SESE |
| K143573 | Audit MicroControls Linearity FD Tumor Markers II | Aalto Scientific, Ltd. | Jan 16, 2015 | SESE |
| K140971 | LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. | Randox Laboratories Limited | Dec 8, 2014 | SESE |
| K142978 | Audit MicroControls Linearity LQ Special Diabetes | Aalto Scientific, Ltd. | Nov 20, 2014 | SESE |
| K133676 | ABX PENTRA MICRO ALB CONTROL L/H | HORIBA ABX SAS | Jul 11, 2014 | SESE |
| K141073 | LIQUICHEK TUMOR MARKER CONTROL | Bio-Rad Laboratories | Jun 23, 2014 | SESE |
| K140522 | RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL | Randox Laboratories Limited | May 22, 2014 | SESE |
| K140916 | LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK | Bio-Rad Laboratories | May 6, 2014 | SESE |
| K140764 | LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK | Bio-Rad Laboratories | Apr 25, 2014 | SESE |
| K134013 | LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO | Bio-Rad Laboratories | Apr 24, 2014 | SESE |
| K140393 | RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3 | Randox Laboratories Limited | Mar 25, 2014 | SESE |
| K133960 | LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL | Bio-Rad Laboratories | Jan 22, 2014 | SESE |
| K132227 | LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY | Bio-Rad Laboratories | Oct 25, 2013 | SESE |
| K132156 | RANDOX CSF CONTROLS LEVELS 2 AND 3 | Randox Laboratories, Ltd. | Oct 23, 2013 | SESE |
Top Applicants
- Bio-Rad — 61 clearances
- Medical Analysis Systems, Inc. — 31 clearances
- Cliniqa Corporation — 22 clearances
- Aalto Scientific, Ltd. — 19 clearances
- Bio-Rad Laboratories — 18 clearances
