Cleared Traditional

K853174 - APO-CHROME IMMUNOASSAY TEST SET FOR APO...

K853174 is the FDA 510(k) clearance for APO-CHROME IMMUNOASSAY TEST SET FOR APO... by Photec Diagnostics, Inc.. It is a Class 1 Immunology device (product code MSJ) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K853174 · Photec Diagnostics, Inc. · Immunology device
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Aug 1985
Decision
23d
Days
Class 1
Risk

K853174 is an FDA 510(k) clearance for the APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN. Classified as Apolipoproteins (product code MSJ), Class I - General Controls.

Submitted by Photec Diagnostics, Inc. (Little Falls, US). The FDA issued a Cleared decision on August 22, 1985 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1475 - 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 K853174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1985
Decision Date August 22, 1985
Days to Decision 23 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 104d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MSJ Apolipoproteins
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
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 - MSJ Apolipoproteins

All 31
Devices cleared under the same product code (MSJ) and FDA review panel - the closest regulatory comparables to K853174.
BIOGRAM APO A1/B
K860629 · Bio-Rad · Mar 1986
ANTISERUM TO HUMAN APOLIPOPROTEIN B
K850690 · Kent Laboratories, Inc. · Nov 1985
ANTISERUM TO HUMAN APOLIPOPROTEIN A-I
K850691 · Kent Laboratories, Inc. · Nov 1985
THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL
K851641 · Ortho Diagnostic Systems, Inc. · Jul 1985
LASER APO A-I TEST APOLIPOPROTEIN A-I REAGENTS
K850638 · Behring Diagnostics, Inc. · May 1985