Cleared Traditional

K935056 - FACTOR VII DEFICIENT PLASMA

K935056 is the FDA 510(k) clearance for FACTOR VII DEFICIENT PLASMA by Sigma Diagnostics, Inc.. It is a Class 2 Hematology device (product code GJT) cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K935056 · Sigma Diagnostics, Inc. · Hematology device
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Mar 1994
Decision
137d
Days
Class 2
Risk

K935056 is an FDA 510(k) clearance for the FACTOR VII DEFICIENT PLASMA. Classified as Plasma, Coagulation Factor Deficient (product code GJT), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 7, 1994 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K935056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1993
Decision Date March 07, 1994
Days to Decision 137 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 113d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GJT Plasma, Coagulation Factor Deficient
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 - GJT Plasma, Coagulation Factor Deficient

All 60
Devices cleared under the same product code (GJT) and FDA review panel - the closest regulatory comparables to K935056.
BIOMERIEUX HEMOLAB COFAC X
K935851 · Biomerieux Vitek, Inc. · Jan 1995
FACTOR VIII DEFICIENT PLASMA
K935057 · Sigma Diagnostics, Inc. · Mar 1994
FACTOR X DEFICIENT PLASMA
K935054 · Sigma Diagnostics, Inc. · Mar 1994
FACTOR
K935058 · Sigma Diagnostics, Inc. · Mar 1994
STAGO FACTOR V-DEFICIENT PLASMA
K934605 · American Bioproducts Co. · Mar 1994
STAGO FACTOR II-DEFICIENT PLASMA
K934606 · American Bioproducts Co. · Mar 1994