Cleared Traditional

K843935 - MODIFICATION MICROTRAK DIRECT SPECIMEN TEST

K843935 is an FDA 510(k) clearance for MODIFICATION MICROTRAK DIRECT SPECIMEN TEST, manufactured by Syva Co.. The device is a Class 1 Microbiology device with product code LIO cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K843935 · Syva Co. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K843935

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.

LIO Device Classification - Class 1, General Controls

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.

Regulatory Peers - LIO Device, Specimen Collection

All 33
Devices cleared under the same product code (LIO) and FDA review panel - the closest regulatory comparables to K843935.
NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT
K871860 · Bio-Rad · May 1987
MODIFIED PATHFINDER SPECIMEN COLLECTION KIT
K870963 · Kallestad Diag, A Div. of Erbamont, Inc. · Apr 1987
IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT
K862607 · Boots-Celltech Diagnostics, Inc. · Aug 1986
SANI CATCH BA
K833814 · Concord Laboratories, Inc. · Mar 1984
PRESERV SAF FIXATIVE 15ML
K834566 · Preventive Diagnostics Corp. · Feb 1984
PRESERV MF FIXATIVE 15ML
K840086 · Preventive Diagnostics Corp. · Jan 1984