Cleared Traditional

VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323 (K052645) - FDA 510(k) Clearance

Also marketed or referenced as:
VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873

Class I Microbiology device.

K052645 · Ortho-Clinical Diagnostics · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
79d
Days
Class 1
Risk

K052645 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323. Classified as Antistreptolysin - Titer/streptolysin O Reagent (product code GTQ), Class I - General Controls.

Submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on December 14, 2005 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3720 - the FDA microbiology device 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 Ortho-Clinical Diagnostics devices

Submission Details

510(k) Number K052645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2005
Decision Date December 14, 2005
Days to Decision 79 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 102d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GTQ Antistreptolysin - Titer/streptolysin O Reagent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3720
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.