TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5— 510(k) K072892
Substantially EquivalentBiosite Incorporated
FDA 510(k) clearance K072892 for TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5, Substantially Equivalent on 2007-12-07. Applicant: Biosite Incorporated. Device class: 1.
Clearance details
- Applicant
- Biosite Incorporated
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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More clearances from Biosite Incorporated
view allRecalls naming K072892
K-number listed on FDA's recall record- Z-3054-2020 — Control, Calibrator Verified, Triage BNP, Model ALR88755
- Z-0588-2017 — Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5 are quality control materials that are used to assist the laboratory in monitoring test performance throughout the measurable range. They are not calibrators and are not used to calibrate the Triage tests. The results of quality control testing do not impact direct patient care and should not influence clinical decision making process the physician uses to make clinical diagnosis for the patient. Indications for Use: The Alere Triage Total 5 Controls are assayed materials to be used with the Alere Triage Cardiac Panel, Alere Triage CardioProfiler Panel, Alere Triage Profiler SOB Panel, Alere Triage BNP Test, Alere Triage D-Dimer Test, and Alere Triage Meters to assist the laboratory in monitoring test performance.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072892.
Data sourced from openFDA. This site is unofficial and independent of the FDA.