Cleared Traditional

MODIFICATION MICROTRAK DIRECT SPECIMEN TEST (K843935) - FDA 510(k) Clearance

Class I Microbiology device.

K843935 · Syva Co. · Microbiology device
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Oct 1984
Decision
18d
Days
Class 1
Risk

K843935 is an FDA 510(k) clearance for the MODIFICATION MICROTRAK DIRECT SPECIMEN TEST. Classified as Device, Specimen Collection (product code LIO), Class I - General Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on October 23, 1984 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - 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 Syva Co. devices

Submission Details

510(k) Number K843935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1984
Decision Date October 23, 1984
Days to Decision 18 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 102d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIO Device, Specimen Collection
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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.