Cleared Traditional

K930212 - THROMBOPLATIN-M WITH CALCIUM

K930212 is an FDA 510(k) clearance for THROMBOPLATIN-M WITH CALCIUM, manufactured by Sigma Diagnostics, Inc.. The device is a Class 2 Hematology device with product code GJS cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K930212 · Sigma Diagnostics, Inc. · Hematology device
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May 1993
Decision
116d
Days
Class 2
Risk

K930212 is an FDA 510(k) clearance for the THROMBOPLATIN-M WITH CALCIUM. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on May 11, 1993 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7750 - 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

FDA 510(k) Submission Details - K930212

510(k) Number K930212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1993
Decision Date May 11, 1993
Days to Decision 116 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
3d slower than avg
Panel avg: 113d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GJS Device Classification - Class 2, Special Controls

Product Code GJS Test, Time, Prothrombin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7750
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 - GJS Test, Time, Prothrombin

All 112
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K930212.
ASSESS(TM) LOW ABNORMAL CONTROL
K931117 · Instrumentation Laboratory CO · Mar 1994
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K931118 · Instrumentation Laboratory CO · Mar 1994
IL TEST (TM) PT-FIBRINOGEN HS PLUS
K933252 · Instrumentation Laboratory CO · Oct 1993
ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT
K925604 · Ortho Diagnostic Systems, Inc. · Mar 1993
BIOMERIEUX HEMOLAB THROMBOMAT
K925492 · Biomerieux Vitek, Inc. · Feb 1993
NEOPLASTINE(R) CI KIT
K922565 · American Bioproducts Co. · Dec 1992