JIT · Calibrator, Secondary
Clinical Chemistry · 21 CFR 862.1150 · Class 2
Overview
| Product Code | JIT |
|---|---|
| Device Name | Calibrator, Secondary |
| 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 245)
Showing 20 most recent of 245 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K171168 | VITROS Immunodiagnostic Products Insulin Calibrators | Ortho Clinical Diagnostics | May 16, 2017 | SESE |
| K170938 | CalSet IGF-1 | Roche Diagnostics | Apr 26, 2017 | SESE |
| K170160 | Abbott ARCHITECT Free T3 | Abbott Laboratories | Feb 15, 2017 | SESE |
| K163546 | Lumipulse G Progesterone-N Calibrators | Fujirebio Diagnostics,Inc. | Jan 13, 2017 | SESE |
| K163534 | Lumipulse G FSH-N Calibrators | Fujirebio Diagnostics,Inc. | Jan 13, 2017 | SESE |
| K163544 | Lumipulse G Prolactin | Fujirebio Diagnostics,Inc. | Jan 12, 2017 | SESE |
| K163521 | Lumipulse G LH Calibrators | Fujirebio Diagnostics,Inc. | Jan 12, 2017 | SESE |
| K163078 | DC-UIBC-CAL | Sekisui Diagnostics P.E.I., Inc. | Dec 8, 2016 | SESE |
| K163053 | Lumipulse G E2-III Calibrators | Fujirebio Diagnostics,Inc. | Dec 1, 2016 | SESE |
| K162538 | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator | Siemens Healthcare Diagnostics | Nov 17, 2016 | SESE |
| K160113 | ST AIA-PACK hsE2 Calibrator Set | Tosoh Bioscience, Inc. | Feb 17, 2016 | SESE |
| K153417 | ST AIA-PACK PROG III Calibrator Set | Tosoh Bioscience, Inc. | Dec 18, 2015 | SESE |
| K152526 | Elecsys Progesterone III CalSet | Roche Diagnostics | Oct 2, 2015 | SESE |
| K151566 | Abbott ARCHITECT Total T4 Calibrators | Abbott Laboratories | Jul 10, 2015 | SESE |
| K142985 | UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator | Beckman Coulter, Inc. | Feb 26, 2015 | SESE |
| K143342 | Elecsys T-Uptake Calset | Roche Diagnostics | Dec 19, 2014 | SESE |
| K143144 | ST AIA-PACK PROG II Calibrator Set | Tosoh Bioscience, Inc. | Dec 3, 2014 | SESE |
| K142181 | RANDOX ALDOLASE CALIBRATION SERUM | Randox Laboratories Limited | Sep 18, 2014 | SESE |
| K142021 | Elecsys Estradiol III CalSet | Roche Diagnostics | Aug 12, 2014 | SESE |
| K133751 | DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS | Diamond Diagnostics, Inc. | Aug 8, 2014 | SESE |
Top Applicants
- Dade Behring, Inc. — 29 clearances
- Wako Chemicals USA, Inc. — 15 clearances
- E.I. Dupont DE Nemours & Co., Inc. — 10 clearances
- Roche Diagnostics Corp. — 10 clearances
- Diamond Diagnostics, Inc. — 9 clearances
