Cleared Traditional

QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3 (K993715) - FDA 510(k) Clearance

Class I Immunology device.

K993715 · Seracare Technology · Immunology device
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Nov 1999
Decision
13d
Days
Class 1
Risk

K993715 is an FDA 510(k) clearance for the QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Seracare Technology (Austin, US). The FDA issued a Cleared decision on November 16, 1999 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - the FDA immunology 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 Seracare Technology devices

Submission Details

510(k) Number K993715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1999
Decision Date November 16, 1999
Days to Decision 13 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 104d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJT Enzyme 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 - JJT Enzyme Controls (assayed And Unassayed)

All 96
Devices cleared under the same product code (JJT) and FDA review panel - the closest regulatory comparables to K993715.
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K961828 · Bio-Rad · Jun 1996