Cleared Traditional

K901660 - QUIDEL CHLAMYDIA TEST

K901660 is an FDA 510(k) clearance for QUIDEL CHLAMYDIA TEST, manufactured by Quidel Corp.. The device is a Class 1 Microbiology device with product code LJC cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K901660 · Quidel Corp. · Microbiology device
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Jul 1990
Decision
108d
Days
Class 1
Risk

K901660 is an FDA 510(k) clearance for the QUIDEL CHLAMYDIA TEST. Classified as Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (product code LJC), Class I - General Controls.

Submitted by Quidel Corp. (San Diego, US). The FDA issued a Cleared decision on July 27, 1990 after a review of 108 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Quidel Corp. devices

FDA 510(k) Submission Details - K901660

510(k) Number K901660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1990
Decision Date July 27, 1990
Days to Decision 108 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
6d slower than avg
Panel avg: 102d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

LJC Device Classification - Class 1, General Controls

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 51
Devices cleared under the same product code (LJC) and FDA review panel - the closest regulatory comparables to K901660.
QUIDEL CHLAMYDIA POSITIVE CONTROL
K903765 · Quidel Corp. · Oct 1990
SYVA MICROTRAK EIA ACCESSORY REAGENTS
K903758 · Syva Co. · Sep 1990
CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY
K902270 · Ciba Corning Diagnostics Corp. · Jul 1990
PATHFINDER(TM) CHLAMYDIA MICROPLATE KIT
K902253 · Kallestad Diag, A Div. of Erbamont, Inc. · Jul 1990
KODAK SURECELL(TM) CHLAMYDIA CONTROL FLUID SET
K901934 · Eastman Kodak Company · Jun 1990
CHLAMYDIAZYME DIAGNOSTIC KIT
K900543 · Abbott Laboratories · May 1990