Cleared Traditional

K072892 - TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5

K072892 is an FDA 510(k) clearance for TRIAGE TOTAL CONTROLS 5, manufactured by Biosite Incorporated. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K072892 · Biosite Incorporated · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
58d
Days
Class 1
Risk

K072892 is an FDA 510(k) clearance for the TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Biosite Incorporated (San Diego, US). The FDA issued a Cleared decision on December 7, 2007 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biosite Incorporated devices

FDA 510(k) Submission Details - K072892

510(k) Number K072892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2007
Decision Date December 07, 2007
Days to Decision 58 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 88d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJY Multi-analyte Controls, All Kinds (assayed)

All 594
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K072892.
MSC LIPID CONTROL
K082067 · Maine Standards Co. · Aug 2008
CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3
K080973 · Cliniqa Corporation · Jun 2008
QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945
K073080 · Bio-Rad Laboratories · Jan 2008
VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601
K072246 · Maine Standards Co. · Sep 2007
DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H
K071980 · Dade Behring, Inc. · Sep 2007
LIQUICHEK TUMOR MARKER CONTROL
K071675 · Bio-Rad Laboratories · Jul 2007