Cleared Traditional

APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 (K853048) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K853048 · Photec Diagnostics, Inc. · Immunology device
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Aug 1985
Decision
40d
Days
Class 2
Risk

K853048 is an FDA 510(k) clearance for the APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1. Classified as Alpha-1-lipoprotein, Antigen, Antiserum, Control (product code DER), Class II - Special Controls.

Submitted by Photec Diagnostics, Inc. (Little Falls, US). The FDA issued a Cleared decision on August 28, 1985 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5580 - 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 Photec Diagnostics, Inc. devices

Submission Details

510(k) Number K853048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1985
Decision Date August 28, 1985
Days to Decision 40 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 104d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DER Alpha-1-lipoprotein, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5580
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 - DER Alpha-1-lipoprotein, Antigen, Antiserum, Control

All 16
Devices cleared under the same product code (DER) and FDA review panel - the closest regulatory comparables to K853048.
TINA-QUANT APOLIPOPROTEIN VER.2
K013249 · Roche Diagnostics Corp. · Nov 2001
INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1
K990594 · Roche Diagnostics Corp. · Apr 1999
APOLIPOPROTEIN A1
K983289 · Abbott Laboratories · Jan 1999
ROCHE APOLIPOPROTEIN STANDARD
K910553 · Roche Diagnostic Systems, Inc. · May 1991