Cleared Traditional

K923322 - TRACE ALBUMIN-MR REAGENT

K923322 is the FDA 510(k) clearance for TRACE ALBUMIN-MR REAGENT by Trace Scientific , Ltd.. It is a Class 2 Hematology device (product code CIX) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K923322 · Trace Scientific , Ltd. · Hematology device
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Sep 1992
Decision
66d
Days
Class 2
Risk

K923322 is an FDA 510(k) clearance for the TRACE ALBUMIN-MR REAGENT. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Trace Scientific , Ltd. (Miami, US). The FDA issued a Cleared decision on September 11, 1992 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1035 - the FDA hematology 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 Trace Scientific , Ltd. devices

Submission Details

510(k) Number K923322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1992
Decision Date September 11, 1992
Days to Decision 66 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 113d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIX Bromcresol Green Dye-binding, Albumin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1035
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 Hematology devices follow this clearance model.

Regulatory Peers - CIX Bromcresol Green Dye-binding, Albumin

All 77
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K923322.
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K914888 · Technicon Instruments Corp. · Nov 1991
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K913920 · Em Diagnostic Systems, Inc. · Sep 1991