Cleared Traditional

ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY (K935807) - FDA 510(k) Clearance

Class I Microbiology device.

K935807 · Bio-Rad Laboratories, Inc. · Microbiology device
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May 1995
Decision
533d
Days
Class 1
Risk

K935807 is an FDA 510(k) clearance for the ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY. Classified as Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (product code LJC), Class I - General Controls.

Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on May 19, 1995 after a review of 533 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3120 - 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: 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 Microbiology submissions.

View all Bio-Rad Laboratories, Inc. devices

Submission Details

510(k) Number K935807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1993
Decision Date May 19, 1995
Days to Decision 533 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
431d slower than avg
Panel avg: 102d · This submission: 533d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJC Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3120
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 - LJC Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)

All 66
Devices cleared under the same product code (LJC) and FDA review panel - the closest regulatory comparables to K935807.
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MICRO TRAK XL SYSTEM
K921747 · Syva Co. · Oct 1992
SYVA MICROTRAK CHLAMYDIA EIA
K920503 · Syva Co. · Sep 1992
MICROTRAK(R) II CHLAMYDIA EIA ASSAY
K921462 · Syva Co. · Sep 1992
SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION
K905179 · Syva Co. · Mar 1991