Cleared Traditional

K031924 - VITROS 5

K031924 is the FDA 510(k) clearance for VITROS 5 by Ortho-Clinical Diagnostics. It is a Class 2 Chemistry device (product code JIT) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K031924 · Ortho-Clinical Diagnostics · Chemistry device
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Optimized for regulatory review, auditing and printing
Aug 2003
Decision
45d
Days
Class 2
Risk

K031924 is an FDA 510(k) clearance for the VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, .... Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on August 7, 2003 after a review of 45 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 devices

Submission Details

510(k) Number K031924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2003
Decision Date August 07, 2003
Days to Decision 45 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
43d faster than avg
Panel avg: 88d · This submission: 45d
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 K031924.
OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296
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ABBOTT ARCHITECT ESTRADIOL CALIBRATORS
K032458 · Abbott Laboratories · Oct 2003
OLYMPUS PREALBUMIN CALIBRATOR, ODR3029
K032285 · Olympus America, Inc. · Aug 2003
ELECSYS LH CALSET II
K031299 · Roche Diagnostics Corp. · May 2003
DIMENSION TPSA CALIBRATOR, MODEL #RC459
K020980 · Dade Behring, Inc. · Jun 2002
DIMENSION ALDL CALIBRATOR, MODEL DC131
K020723 · Dade Behring, Inc. · May 2002