Cleared Traditional

K952055 - ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAY

K952055 is the FDA 510(k) clearance for ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAY by American Laboratory Products Co., Ltd.. It is a Class 2 Immunology device (product code LRM) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K952055 · American Laboratory Products Co., Ltd. · Immunology device
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Jul 1995
Decision
77d
Days
Class 2
Risk

K952055 is an FDA 510(k) clearance for the ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAY. Classified as Anti-dna Antibody (enzyme-labeled), Antigen, Control (product code LRM), Class II - Special Controls.

Submitted by American Laboratory Products Co., Ltd. (Windham, US). The FDA issued a Cleared decision on July 18, 1995 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - the FDA immunology 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 American Laboratory Products Co., Ltd. devices

Submission Details

510(k) Number K952055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1995
Decision Date July 18, 1995
Days to Decision 77 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 104d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LRM Anti-dna Antibody (enzyme-labeled), Antigen, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
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 Immunology devices follow this clearance model.

Regulatory Peers - LRM Anti-dna Antibody (enzyme-labeled), Antigen, Control

All 14
Devices cleared under the same product code (LRM) and FDA review panel - the closest regulatory comparables to K952055.
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HYTEC AUTOMIMMUNE KIT (DS-DNA)
K954893 · Hycor Biomedical, Inc. · Mar 1996
VARELISA COMBINED DNA ANTIBODIES EIA
K944334 · Elias U.S.A., Inc. · Apr 1995
VARELISA DSDNA ANTIBODIES (FARR VERSION)
K950031 · Elias U.S.A., Inc. · Mar 1995
ANTI-DNA MICROASSAY
K912020 · Diamedix Corp. · Sep 1991