Cleared Traditional

K042521 - VITROS CHEMISTRY PRODUCTS APOA1 AND APO...

K042521 is the FDA 510(k) clearance for VITROS CHEMISTRY PRODUCTS APOA1 AND APO... by Ortho-Clinical Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JIT) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K042521 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
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Nov 2004
Decision
63d
Days
Class 2
Risk

K042521 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 .... Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on November 18, 2004 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 Ortho-Clinical Diagnostics, Inc. devices

Submission Details

510(k) Number K042521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2004
Decision Date November 18, 2004
Days to Decision 63 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
25d faster than avg
Panel avg: 88d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIT Calibrator, Secondary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JIT Calibrator, Secondary

All 159
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K042521.
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23
K042838 · Ortho-Clinical Diagnostics, Inc. · Dec 2004
OLYMPUS LACTATE, OSR6193
K042406 · Olympus America, Inc. · Dec 2004
ROCHE DIAGNOSTICS ELECSYS AFP CALSET II
K043095 · Roche Diagnostics Corp. · Nov 2004
FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
K042651 · Beckman Coulter, Inc. · Oct 2004
ELECSYS FOLATE II CALSET II
K042490 · Roche Diagnostics Corp. · Sep 2004
AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR
K033860 · Wako Chemicals USA, Inc. · Apr 2004