Cleared Traditional

QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL) (K852418) - FDA 510(k) Clearance

Class I Immunology device.

K852418 · Amf Biological and Diagnostics Co. · Immunology device
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Jul 1985
Decision
38d
Days
Class 1
Risk

K852418 is an FDA 510(k) clearance for the QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL). Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Amf Biological and Diagnostics Co. (Seguin, US). The FDA issued a Cleared decision on July 15, 1985 after a review of 38 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 Amf Biological and Diagnostics Co. devices

Submission Details

510(k) Number K852418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1985
Decision Date July 15, 1985
Days to Decision 38 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 104d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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)

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