Cleared Traditional

K003767 - ASSERACHROM HPIA TEST KIT

K003767 is an FDA 510(k) clearance for ASSERACHROM HPIA TEST KIT, manufactured by Diagnostica Stago, Inc.. The device is a Class 2 Hematology device with product code LCO cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K003767 · Diagnostica Stago, Inc. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
68d
Days
Class 2
Risk

K003767 is an FDA 510(k) clearance for the ASSERACHROM HPIA TEST KIT. Classified as Platelet Factor 4 Radioimmunoassay (product code LCO), Class II - Special Controls.

Submitted by Diagnostica Stago, Inc. (Parsippany, US). The FDA issued a Cleared decision on February 12, 2001 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7695 - 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.

FDA 510(k) Submission Details - K003767

510(k) Number K003767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2000
Decision Date February 12, 2001
Days to Decision 68 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 113d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCO Device Classification - Class 2, Special Controls

Product Code LCO Platelet Factor 4 Radioimmunoassay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7695
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 - LCO Platelet Factor 4 Radioimmunoassay

All 12
Devices cleared under the same product code (LCO) and FDA review panel - the closest regulatory comparables to K003767.
ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A
K071255 · Hyphen Biomed · Sep 2007
PF4 ENHANCED SOLID PHASE ELISA
K053559 · Genetic Testing Institute · Jan 2006
HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY
K040293 · Akers Laboratories, Inc. · May 2004
GTI-PF4 ELISA
K983379 · Genetic Testing Institute · Mar 1999
ENZYGNOST PLATELET FACTOR 4 (PF4) KIT
K890633 · Behring Diagnostics, Inc. · Apr 1989
ASSERACHROM PF4 KIT
K862774 · American Bioproducts Co. · Sep 1986
K003767 · ASSERACHROM HPIA TEST KIT
Download PDF FDA Summary Diagnostica Stago, In…