Cleared Traditional

K901243 - CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST

K901243 is an FDA 510(k) clearance for CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST, manufactured by Cel Labs Pty, Ltd.. The device is a Class 1 Microbiology device with product code LJP cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K901243 · Cel Labs Pty, Ltd. · Microbiology device
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May 1990
Decision
67d
Days
Class 1
Risk

K901243 is an FDA 510(k) clearance for the CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST. Classified as Antiserum, Fluorescent, Chlamydia Trachomatis (product code LJP), Class I - General Controls.

Submitted by Cel Labs Pty, Ltd. (Washington, US). The FDA issued a Cleared decision on May 21, 1990 after a review of 67 days - a notably fast clearance cycle.

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: 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 Cel Labs Pty, Ltd. devices

FDA 510(k) Submission Details - K901243

510(k) Number K901243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1990
Decision Date May 21, 1990
Days to Decision 67 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 102d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

LJP Device Classification - Class 1, General Controls

Product Code LJP Antiserum, Fluorescent, Chlamydia Trachomatis
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 - LJP Antiserum, Fluorescent, Chlamydia Trachomatis

All 31
Devices cleared under the same product code (LJP) and FDA review panel - the closest regulatory comparables to K901243.
DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT
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K941714 · Neogenex · Jul 1994
PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST
K900870 · Diagnostic Products Corp. · Apr 1990
PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1
K895839 · Diagnostic Products Corp. · Feb 1990
FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI
K883352 · Whittaker Bioproducts, Inc. · Oct 1988
ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST
K881500 · Ortho Diagnostic Systems, Inc. · Apr 1988