JJS · Controls For Blood-Gases, (Assayed And Unassayed)
Clinical Chemistry · 21 CFR 862.1660 · Class 1
Overview
| Product Code | JJS |
|---|---|
| Device Name | Controls For Blood-Gases, (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 67)
Showing 20 most recent of 67 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K152553 | CueSee Hypoxic | Eurotrol B.V. | Apr 22, 2016 | SESE |
| K150226 | Hematocrit and Metabolite QUALICHECK | Radiometer Medical Aps | May 13, 2015 | SESE |
| K130415 | HIGH METABOLITE QUALICHECK | Radiometer Medical Aps | Mar 26, 2013 | SESE |
| K130236 | RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3 | Radiometer Medical Aps | Mar 15, 2013 | SESE |
| K033063 | MISSION CONTROLS | Diamond Diagnostics, Inc. | Dec 12, 2003 | SESE |
| K022529 | LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669 | Bio-Rad | Aug 15, 2002 | SESE |
| K022525 | LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509 | Bio-Rad | Aug 15, 2002 | SESE |
| K003242 | LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623 | Bio-Rad | Nov 30, 2000 | SESE |
| K003239 | LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506 | Bio-Rad | Nov 30, 2000 | SESE |
| K002866 | LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574 | Bio-Rad | Sep 25, 2000 | SESE |
| K002865 | LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578 | Bio-Rad | Sep 25, 2000 | SESE |
| K002536 | LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER) | Bio-Rad | Aug 30, 2000 | SESE |
| K002535 | LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513 | Bio-Rad | Aug 30, 2000 | SESE |
| K002120 | LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573 | Bio-Rad | Aug 21, 2000 | SESE |
| K980135 | QUALICHECK5+ MODELS S7730, S7740, S7750, S7760 | Radiometer America, Inc. | Jan 28, 1998 | SESE |
| K972861 | IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3) | Instrumentation Laboratory CO | Aug 19, 1997 | SESE |
| K961355 | MULTICHECK | Radiometer America, Inc. | Jun 14, 1996 | SESE |
| K961354 | QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660) | Radiometer America, Inc. | Jun 14, 1996 | SESE |
| K961441 | TONOMETERED SLAINE BLOOD GAS CONTROL | Instrumentarium Corp. | Apr 30, 1996 | SESE |
| K955340 | EUROTROL GAS - ISE CONTROL | Direct Solutions | Dec 26, 1995 | SESE |
Top Applicants
- Radiometer America, Inc. — 9 clearances
- Bio-Rad — 9 clearances
- Phoenix Diagnostics, Inc. — 5 clearances
- Bionostics, Inc. — 5 clearances
- Radiometer Medical Aps — 3 clearances
