JJR · Electrolyte Controls (Assayed And Unassayed)
Clinical Chemistry · 21 CFR 862.1660 · Class 1
Overview
| Product Code | JJR |
|---|---|
| Device Name | Electrolyte 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.
Cleared Devices (17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K990971 | EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816 | Medica Corp. | Apr 27, 1999 | SESE |
| K960592 | ELECTROLYTE STANDARDS | Phoenix Diagnostics, Inc. | May 13, 1996 | SESE |
| K955630 | RNA MEDICAL HEMAT CONTROL | Bionostics, Inc. | Mar 1, 1996 | SESE |
| K951435 | AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL | Aalto Scientific, Ltd. | May 2, 1995 | SESE |
| K943925 | SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING | Quantimetrix Corp. | Oct 4, 1994 | SESE |
| K934641 | I-STAT CONTROL LEVELS 1,2,3 | I-Stat Corp. | Dec 9, 1993 | SESE |
| K912513 | ELECTROLYTE CONTROL | Verichem Laboratories, Inc. | Jul 19, 1991 | SESE |
| K902266 | ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED) | Phoenix Diagnostics, Inc. | Jun 6, 1990 | SESE |
| K894576 | CIBA CORNING CERTAIN LYTE | Ciba Corning Diagnostics Corp. | Oct 30, 1989 | SESE |
| K895582 | QCLYTE PROTEIN-BASED ISE CONTROL | Baxter Healthcare Corp | Oct 4, 1989 | SESE |
| K881773 | DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET | Casco Standards | Jun 10, 1988 | SESE |
| K881655 | SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL | Biomedical Research & Development Laboratories, Inc. | May 27, 1988 | SESE |
| K880710 | PROTEIN BASE ISE CONTROL | Bionostics, Inc. | Mar 24, 1988 | SESE |
| K863333 | AVL ISE-TROL ELECTROLYTE CONTROL | Avl Scientific Corp. | Sep 29, 1986 | SESE |
| K834505 | HUMAN SERUM ELECTROLYTE CONTROL-LIQUID | Quantimetrix Corp. | Apr 13, 1984 | SESE |
| K831389 | STAT-TRAK LIQUID ELECTROLYTE CONTROL | United Diagnostics, Inc. | Aug 10, 1983 | SESE |
| K792196 | 8 SUBJECT PHOTOVOLT ELECTROLYTE SERUM CO | Photovolt Corp. | Nov 13, 1979 | SESE |
Top Applicants
- Quantimetrix Corp. — 2 clearances
- Phoenix Diagnostics, Inc. — 2 clearances
- Bionostics, Inc. — 2 clearances
- Verichem Laboratories, Inc. — 1 clearance
- United Diagnostics, Inc. — 1 clearance
