Cleared Traditional

HEPAQUANT (K813011) - FDA 510(k) Clearance

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

K813011 · Streck Laboratories, Inc. · Pathology device
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Jan 1982
Decision
91d
Days
Class 2
Risk

K813011 is an FDA 510(k) clearance for the HEPAQUANT. Classified as Analyzer, Heparin, Automated (product code JOX), Class II - Special Controls.

Submitted by Streck Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 26, 1982 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.5680 - the FDA pathology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Streck Laboratories, Inc. devices

Submission Details

510(k) Number K813011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1981
Decision Date January 26, 1982
Days to Decision 91 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 77d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOX Analyzer, Heparin, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5680
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 Pathology devices follow this clearance model.

Regulatory Peers - JOX Analyzer, Heparin, Automated

All 14
Devices cleared under the same product code (JOX) and FDA review panel - the closest regulatory comparables to K813011.
HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)
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K102953 · Medtronic, Inc. · Nov 2010
HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX
K101271 · Medtronic, Inc. · Oct 2010
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
K043080 · Medtronic Vascular · Dec 2004
HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20
K042070 · Medtronic Vascular · Oct 2004