Cleared Traditional

K932145 - COAGULATION REFERENCE PLASMA, NORMAL

K932145 is an FDA 510(k) clearance for COAGULATION REFERENCE PLASMA, manufactured by American Diagnostic Corp.. The device is a Class 2 Hematology device with product code GIZ cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K932145 · American Diagnostic Corp. · Hematology device
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Oct 1993
Decision
167d
Days
Class 2
Risk

K932145 is an FDA 510(k) clearance for the COAGULATION REFERENCE PLASMA, NORMAL. Classified as Plasma, Control, Normal (product code GIZ), Class II - Special Controls.

Submitted by American Diagnostic Corp. (Greenwich, US). The FDA issued a Cleared decision on October 18, 1993 after a review of 167 days - an extended review 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: 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 American Diagnostic Corp. devices

FDA 510(k) Submission Details - K932145

510(k) Number K932145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1993
Decision Date October 18, 1993
Days to Decision 167 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
54d slower than avg
Panel avg: 113d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GIZ Device Classification - Class 2, Special Controls

Product Code GIZ Plasma, Control, Normal
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 - GIZ Plasma, Control, Normal

All 14
Devices cleared under the same product code (GIZ) and FDA review panel - the closest regulatory comparables to K932145.
ACCUCOLOR HIGH CALIBRATOR (A3089)
K973274 · Sigma Diagnostics, Inc. · Oct 1997
SPECIALTY ASSAYED CONTROL-1
K941737 · Helena Laboratories · Oct 1994
CONTROL PLASMA N
K924403 · Behring Diagnostics, Inc. · Feb 1994
UNICALIBRATOR KIT
K922021 · American Bioproducts Co. · Jun 1992
COAGULATION REFERENCE PLASMA, NORMAL
K905203 · Medical Diagnostic Technologies, Inc. · Dec 1990
NORMAL COAGULATION CONTROL PLASMA (NCCP)
K895262 · Medical Diagnostic Technologies, Inc. · Oct 1989