Cleared Traditional

ASSERACHROM HPIA TEST KIT (K003767) - FDA 510(k) Clearance

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

K003767 · Diagnostica Stago, Inc. · Hematology device
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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.

View all Diagnostica Stago, Inc. devices

Submission Details

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
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.

Device Classification

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
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