Cleared Traditional

BIOTIS ABNORMAL CLINICAL CHEM SERUM- (K840458) - FDA 510(k) Clearance

Class I Microbiology device.

K840458 · Otisville Biotech, Inc. · Microbiology device
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Apr 1984
Decision
75d
Days
Class 1
Risk

K840458 is an FDA 510(k) clearance for the BIOTIS ABNORMAL CLINICAL CHEM SERUM-. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Otisville Biotech, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 17, 1984 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.1660 - the FDA microbiology 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 Otisville Biotech, Inc. devices

Submission Details

510(k) Number K840458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1984
Decision Date April 17, 1984
Days to Decision 75 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 102d · This submission: 75d
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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