MJX · Kit, Serological, Positive Control
Clinical Chemistry · 21 CFR 862.1660 · Class 1
Overview
| Product Code | MJX |
|---|---|
| Device Name | Kit, Serological, 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 (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K101434 | AUDIT MICROCV PROCALCITONIN LINEARITY | Aalto Scientific, Ltd. | Jul 22, 2010 | SESE |
| K030067 | VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS | Ortho-Clinical Diagnostics | Jan 17, 2003 | SESE |
| K974262 | SYSCOS IDC - G, IDC, BSC, IDC - G | Scantibodies Laboratory, Inc. | Dec 24, 1997 | SESE |
| K972986 | ACCURUN 140 RUBELLA IGG POSITIVE CONTROL | Boston Biomedica, Inc. | Oct 8, 1997 | SESE |
| K970100 | TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL | Simplicity Diagnostics, Inc. | Mar 10, 1997 | SESE |
| K934137 | OPUS(R) SEROLOGY CONTROLS, MODIFICATION | Pb Diagnostic Systems, Inc. | Mar 7, 1994 | SESE |
| K925703 | OPUS SEROLOGY CONTROLS | Pb Diagnostics, Inc. | Apr 8, 1993 | SESE |
Top Applicants
- Aalto Scientific, Ltd. — 1 clearance
- Boston Biomedica, Inc. — 1 clearance
- Ortho-Clinical Diagnostics — 1 clearance
- Pb Diagnostic Systems, Inc. — 1 clearance
- Pb Diagnostics, Inc. — 1 clearance
