Cleared Traditional

K942647 - COLLEGE OF AMER PATH (CAP) SURV VALID P...

K942647 is an FDA 510(k) clearance for COLLEGE OF AMER PATH (CAP) SURV VALID P..., manufactured by Scantibodies Laboratory, Inc.. The device is a Class 1 Immunology device with product code JJY cleared through the Traditional 510(k) pathway after a 404-day FDA review.

K942647 · Scantibodies Laboratory, Inc. · Immunology device
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Jul 1995
Decision
404d
Days
Class 1
Risk

K942647 is an FDA 510(k) clearance for the COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Scantibodies Laboratory, Inc. (Santee, US). The FDA issued a Cleared decision on July 12, 1995 after a review of 404 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all Scantibodies Laboratory, Inc. devices

FDA 510(k) Submission Details - K942647

510(k) Number K942647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1994
Decision Date July 12, 1995
Days to Decision 404 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
300d slower than avg
Panel avg: 104d · This submission: 404d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 545
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