Cleared Traditional

K761091 - TPC-LYOPHILIZED POOLED HUMAN PLASMA

K761091 is the FDA 510(k) clearance for TPC-LYOPHILIZED POOLED HUMAN PLASMA by Bio/Data Corp.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K761091 · Bio/Data Corp. · Hematology device
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Feb 1977
Decision
71d
Days
Class 2
Risk

K761091 is an FDA 510(k) clearance for the TPC-LYOPHILIZED POOLED HUMAN PLASMA. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Bio/Data Corp. (Mchenry, US). The FDA issued a Cleared decision on February 1, 1977 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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 Bio/Data Corp. devices

Submission Details

510(k) Number K761091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1976
Decision Date February 01, 1977
Days to Decision 71 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
42d faster than avg
Panel avg: 113d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - JPA System, Multipurpose For In Vitro Coagulation Studies

All 116
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K761091.
ELVI 818 DIGICLOT MULTISCAN
K791586 · Volu Sol Medical Industries · Sep 1979
COAG-A-MATE 2001
K790323 · General Diagnostics · Mar 1979
PLASMA, STANDARDIZED NORMAL
K790204 · Dade, Baxter Travenol Diagnostics, Inc. · Mar 1979
VERONAL BUFFER
K761171 · Bio/Data Corp. · Jan 1977
TRIS BUFFERED SALINE
K761172 · Bio/Data Corp. · Jan 1977
TRIS BUFFERED
K761173 · Bio/Data Corp. · Jan 1977