Cleared Traditional

K800605 - ANA LATEX SLIDE TEST

K800605 is the FDA 510(k) clearance for ANA LATEX SLIDE TEST by Biologics Intl., Inc.. It is a Class 2 Microbiology device (product code DHC) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K800605 · Biologics Intl., Inc. · Microbiology device
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Apr 1980
Decision
16d
Days
Class 2
Risk

K800605 is an FDA 510(k) clearance for the ANA LATEX SLIDE TEST. Classified as System, Test, Systemic Lupus Erythematosus (product code DHC), Class II - Special Controls.

Submitted by Biologics Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on April 2, 1980 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.5820 - 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 Biologics Intl., Inc. devices

Submission Details

510(k) Number K800605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1980
Decision Date April 02, 1980
Days to Decision 16 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 102d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHC System, Test, Systemic Lupus Erythematosus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5820
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - DHC System, Test, Systemic Lupus Erythematosus

All 8
Devices cleared under the same product code (DHC) and FDA review panel - the closest regulatory comparables to K800605.
SLE ANTI-N-DNA LATEX TEST
K810226 · Icl Scientific · Feb 1981
CORDIA N
K800991 · Cordis Corp. · May 1980
CORDIA NP
K800992 · Cordis Corp. · May 1980
IIF-A-N-DNA TEST KIT
K790106 · Medica Corp. · Mar 1979
SYSTEMIC LUPUS
K790257 · Icl Scientific · Mar 1979
LUPO-TEC
K782129 · Armkel, LLC · Mar 1979