Cleared Traditional

K922021 - UNICALIBRATOR KIT

K922021 is the FDA 510(k) clearance for UNICALIBRATOR KIT by American Bioproducts Co.. It is a Class 2 Hematology device (product code GIZ) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K922021 · American Bioproducts Co. · Hematology device
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Jun 1992
Decision
40d
Days
Class 2
Risk

K922021 is an FDA 510(k) clearance for the UNICALIBRATOR KIT. Classified as Plasma, Control, Normal (product code GIZ), Class II - Special Controls.

Submitted by American Bioproducts Co. (Parsippany, US). The FDA issued a Cleared decision on June 9, 1992 after a review of 40 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 American Bioproducts Co. devices

Submission Details

510(k) Number K922021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1992
Decision Date June 09, 1992
Days to Decision 40 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
73d faster than avg
Panel avg: 113d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 12
Devices cleared under the same product code (GIZ) and FDA review panel - the closest regulatory comparables to K922021.
SPECIALTY ASSAYED CONTROL-1
K941737 · Helena Laboratories · Oct 1994
CONTROL PLASMA N
K924403 · Behring Diagnostics, Inc. · Feb 1994
COAGULATION REFERENCE PLASMA, NORMAL
K932145 · American Diagnostic Corp. · Oct 1993
COAGULATION REFERENCE PLASMA, NORMAL
K905203 · Medical Diagnostic Technologies, Inc. · Dec 1990
NORMAL COAGULATION CONTROL PLASMA (NCCP)
K895262 · Medical Diagnostic Technologies, Inc. · Oct 1989
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I
K893783 · Analytical Control Systems, Inc. · Jun 1989