Cleared Traditional

K012561 - VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-H...

K012561 is the FDA 510(k) clearance for VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-H... by Ortho-Clinical Diagnostics. It is a Class 1 Microbiology device (product code JJX) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K012561 · Ortho-Clinical Diagnostics · Microbiology device
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Aug 2001
Decision
21d
Days
Class 1
Risk

K012561 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on August 29, 2001 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.1660 - 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 K012561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2001
Decision Date August 29, 2001
Days to Decision 21 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 102d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
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 - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 370
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K012561.
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K012430 · Bionostics, Inc. · Aug 2001
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K011250 · Ortho-Clinical Diagnostics, Inc. · Jun 2001
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K011463 · Ortho-Clinical Diagnostics · Jun 2001