Cleared Traditional

K851649 - APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1

K851649 is an FDA 510(k) clearance for APO A-I IMMUNOASSAY TEST SET FOR APOLIP..., manufactured by Photec Diagnostics, Inc.. The device is a Class 2 Immunology device with product code DER cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K851649 · Photec Diagnostics, Inc. · Immunology device
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Jun 1985
Decision
44d
Days
Class 2
Risk

K851649 is an FDA 510(k) clearance for the APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1. 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 June 5, 1985 after a review of 44 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

FDA 510(k) Submission Details - K851649

510(k) Number K851649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1985
Decision Date June 05, 1985
Days to Decision 44 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 105d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DER Device Classification - Class 2, Special Controls

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 12
Devices cleared under the same product code (DER) and FDA review panel - the closest regulatory comparables to K851649.
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