JIS · Calibrator, Primary
Clinical Chemistry · 21 CFR 862.1150 · Class 2
Overview
| Product Code | JIS |
|---|---|
| Device Name | Calibrator, Primary |
| Regulation | 21 CFR 862.1150 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Special Controls
*Classification.* Class II (special controls). The device is 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 130)
Showing 20 most recent of 130 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K122126 | DIRECT LDL/HDL CHOLESTEROL CALIBRATOR | Randox Laboratories Limited | Aug 14, 2012 | SESE |
| K061251 | DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR | Dade Behring, Inc. | May 31, 2006 | SESE |
| K060266 | DIMENSION IRON CALIBRATOR | Dade Behring, Inc. | Mar 9, 2006 | SESE |
| K053104 | DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR | Dade Behring, Inc. | Dec 23, 2005 | SESE |
| K032697 | DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) | Dade Behring, Inc. | Nov 7, 2003 | SESE |
| K032608 | GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER | Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB | Oct 21, 2003 | SESE |
| K032296 | VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS | Ortho-Clinical Diagnostics, Inc. | Aug 13, 2003 | SESE |
| K030964 | CALIBRATION PLASMA LMW HEPARIN | Instrumentation Laboratory CO | Jun 6, 2003 | SESE |
| K030546 | CRP (II) CALIBRATORS | Denka Seiken Co., Ltd. | Jun 2, 2003 | SESE |
| K030320 | WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET | Wako Chemicals USA, Inc. | Apr 11, 2003 | SESE |
| K022682 | RANDOX C-REACTIVE PROTEIN CALIBRATOR | Randox Laboratories, Ltd. | Nov 5, 2002 | SESE |
| K022901 | VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS | Ortho-Clinical Diagnostics | Sep 27, 2002 | SESE |
| K013126 | N LP(A) STANDARD SY | Dade Behring, Inc. | Nov 9, 2001 | SESE |
| K012878 | THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 | Thermo Dma, Inc. | Oct 16, 2001 | SESE |
| K011568 | RANDOX LIPOPROTEIN | Randox Laboratories, Ltd. | Sep 28, 2001 | SESE |
| K010696 | BECKMAN COULTER DNASE B CALIBRATOR | Beckman Coulter, Inc. | May 10, 2001 | SESE |
| K003941 | ELECSYS HCG STAT CLASET II | Roche Diagnostics Corp. | Jan 25, 2001 | SESE |
| K003969 | ELECSYS CA 125 II CALSET | Roche Diagnostics Corp. | Jan 12, 2001 | SESE |
| K002760 | ELECSYS DHEA-S CALSET | Roche Diagnostics Corp. | Oct 5, 2000 | SESE |
| K002353 | ELECSYS CA 15-3 CALCHECK | Roche Diagnostics Corp. | Aug 10, 2000 | SESE |
Top Applicants
- E.I. Dupont DE Nemours & Co., Inc. — 8 clearances
- Wako Chemicals USA, Inc. — 7 clearances
- Beckman Coulter, Inc. — 6 clearances
- Dade Behring, Inc. — 6 clearances
- Syva Co. — 6 clearances
