MJZ · Kit, Direct Antigen, Positive Control
Clinical Chemistry · 21 CFR 862.1660 · Class 1
Overview
| Product Code | MJZ |
|---|---|
| Device Name | Kit, Direct Antigen, Positive Control |
| 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 (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K083744 | BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 | Binax, Inc. | Sep 1, 2009 | SESE |
| K972182 | ABBOTT STREP A CONTROLS | Abbott Diagnostics | Aug 13, 1997 | SESE |
| K972129 | CHLAMYDIATROL AG | Blackhawk Biosystems, Inc. | Aug 12, 1997 | SESE |
Top Applicants
- Abbott Diagnostics — 1 clearance
- Binax, Inc. — 1 clearance
- Blackhawk Biosystems, Inc. — 1 clearance
