Cleared Traditional

K982649 - VITROS CHEMISTRY PRODUCTS TDM PERFORMAN...

K982649 is the FDA 510(k) clearance for VITROS CHEMISTRY PRODUCTS TDM PERFORMAN... by Ortho-Clinical Diagnostics, Inc.. It is a Class 1 Chemistry device (product code DIF) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K982649 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
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Aug 1998
Decision
13d
Days
Class 1
Risk

K982649 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on August 12, 1998 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3280 - 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 K982649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1998
Decision Date August 12, 1998
Days to Decision 13 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 88d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIF Drug Mixture Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
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 - DIF Drug Mixture Control Materials

All 146
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