Cleared Traditional

K881829 - PAT PLATELET AGGREGATION TEST

K881829 is the FDA 510(k) clearance for PAT PLATELET AGGREGATION TEST by Streck Laboratories, Inc.. It is a Class 2 Hematology device (product code JBX) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K881829 · Streck Laboratories, Inc. · Hematology device
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Jul 1988
Decision
63d
Days
Class 2
Risk

K881829 is an FDA 510(k) clearance for the PAT PLATELET AGGREGATION TEST. Classified as Aggregrometer, Platelet (product code JBX), Class II - Special Controls.

Submitted by Streck Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on July 1, 1988 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6675 - 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 Streck Laboratories, Inc. devices

Submission Details

510(k) Number K881829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1988
Decision Date July 01, 1988
Days to Decision 63 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 113d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JBX Aggregrometer, Platelet
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6675
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 - JBX Aggregrometer, Platelet

Devices cleared under the same product code (JBX) and FDA review panel - the closest regulatory comparables to K881829.
ARACHIDONIC ACID
K912774 · Helena Laboratories · Aug 1991
ASSERACHROM B-TG KIT
K862775 · American Bioproducts Co. · Oct 1986
RISTOCETIN PLATELET AGGREGA-REAGENT TEST
K832929 · Sigma Chemical Co. · Sep 1983
PLATELET AGGREGATION PROFILER #PAP-4
K821005 · Bio/Data Corp. · Jun 1982
ARACHIDONIC ACID
K811290 · Bio/Data Corp. · Jul 1981