Cleared Traditional

K812357 - VENTREX DATA REDUCTION & QUAL. CONTR. SY

K812357 is an FDA 510(k) clearance for VENTREX DATA REDUCTION & QUAL. CONTR. SY, manufactured by Ventrex Laboratories, Inc.. The device is a Class 2 Chemistry device with product code JPK cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K812357 · Ventrex Laboratories, Inc. · Chemistry device
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Sep 1981
Decision
12d
Days
Class 2
Risk

K812357 is an FDA 510(k) clearance for the VENTREX DATA REDUCTION & QUAL. CONTR. SY. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Ventrex Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 1, 1981 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.8625 - the FDA in vitro diagnostics and chemistry 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 - K812357

510(k) Number K812357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1981
Decision Date September 01, 1981
Days to Decision 12 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 89d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPK Device Classification - Class 2, Special Controls

Product Code JPK Mixture, Hematology Quality Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
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 Chemistry devices follow this clearance model.

Regulatory Peers - JPK Mixture, Hematology Quality Control

All 191
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K812357.
ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW
K820401 · Orhto Diagnostic Systems, Inc. · Mar 1982
HEMOTOLOGY QUALITY CONTROL MIXTURE
K812237 · American Dade · Sep 1981
HEMATOLOGY CONTROL
K812280 · American Dade · Sep 1981
HEMOTOLOGY QUALITY CONTROL MIXTURES
K810756 · Scientific Standards, Inc. · Jun 1981
THROMBO-TEST (X)
K801054 · Medtro GmbH · Mar 1981
ORTHO HEMATOLOGY CONTROL
K803073 · Ortho Instruments · Dec 1980
K812357 · VENTREX DATA REDUCTION & QUAL. CONTR. SY
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