JJX · Single (Specified) Analyte Controls (Assayed And Unassayed)
Clinical Chemistry · 21 CFR 862.1660 · Class 1
Overview
| Product Code | JJX |
|---|---|
| Device Name | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| 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 493)
Showing 20 most recent of 493 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K170678 | Beta-CrossLaps CalCheck 5 | Roche Diagnostics | Apr 4, 2017 | SESE |
| K162173 | Elecsys CYFRA 21-1 CalCheck 5 | Roche Diagnostics | Jan 12, 2017 | SESE |
| K162514 | Multichem A1c | Technopath Manufacturing | Oct 26, 2016 | SESE |
| K161874 | Audit MicroControls Linearity DROP LQ Blood Glucose | Aalto Scientific, Ltd. | Aug 10, 2016 | SESE |
| K161526 | LIAISON CMV IgM Serum Control Set | DiaSorin, Inc. | Jun 30, 2016 | SESE |
| K161522 | LIAISON EBV IgM Serum Control Set | DiaSorin, Inc. | Jun 30, 2016 | SESE |
| K161082 | IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers | Immunodiagnostic Systems , Ltd. | May 17, 2016 | SESE |
| K152117 | Dropper hsCRP High Sensitivity CRP Control | Quantimetrix Corporation | Apr 21, 2016 | SESE |
| K151742 | Contour Next Control Solution | Bayer Healthcare | Sep 23, 2015 | SESE |
| K143687 | ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material | Siemens Healthcare Diagnostics, Inc. | Jul 17, 2015 | SESE |
| K150955 | Elecsys Progesterone III Cal Check 5 | Roche Diagnostics | May 1, 2015 | SESE |
| K150132 | IMMULITE IGF Control Module, IMMULITE Gastrin Control Module | Siemens Healthcare Diagnostics | Apr 13, 2015 | SESE |
| K143324 | IDS-iSYS CTX-I Calibration Verifiers | Immunodiagnostic Systems , Ltd. | Mar 30, 2015 | SESE |
| K143373 | IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | Feb 26, 2015 | SESE |
| K143636 | IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | Feb 25, 2015 | SESE |
| K143680 | ADVIA Centaur IgE Master Curve Material | Siemens Healthcare Diagnostics, Inc. | Jan 27, 2015 | SESE |
| K143639 | IMMULITE 2000 CEA Calibration Verification Material | Siemens Healthcare Diagnostics | Jan 23, 2015 | SESE |
| K143571 | Audit MicroControls Linearity LQ Cystatin-C | Aalto Scientific, Ltd. | Jan 23, 2015 | SESE |
| K143504 | IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | Jan 14, 2015 | SESE |
| K143352 | IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | Dec 24, 2014 | SESE |
Top Applicants
- Roche Diagnostics — 35 clearances
- Siemens Healthcare Diagnostics, Inc. — 27 clearances
- Boehringer Mannheim Corp. — 24 clearances
- Bionostics, Inc. — 22 clearances
- Roche Diagnostics Corp. — 22 clearances
