Cleared Traditional

K921223 - ACS FREEZE-DRIED APTT REAGENT

K921223 is an FDA 510(k) clearance for ACS FREEZE-DRIED APTT REAGENT, manufactured by Analytical Control Systems, Inc.. The device is a Class 2 Hematology device with product code GFO cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K921223 · Analytical Control Systems, Inc. · Hematology device
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Aug 1992
Decision
158d
Days
Class 2
Risk

K921223 is an FDA 510(k) clearance for the ACS FREEZE-DRIED APTT REAGENT. Classified as Activated Partial Thromboplastin (product code GFO), Class II - Special Controls.

Submitted by Analytical Control Systems, Inc. (Indianapolis, US). The FDA issued a Cleared decision on August 18, 1992 after a review of 158 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7925 - 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 Analytical Control Systems, Inc. devices

FDA 510(k) Submission Details - K921223

510(k) Number K921223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1992
Decision Date August 18, 1992
Days to Decision 158 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
45d slower than avg
Panel avg: 113d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GFO Device Classification - Class 2, Special Controls

Product Code GFO Activated Partial Thromboplastin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7925
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 - GFO Activated Partial Thromboplastin

All 43
Devices cleared under the same product code (GFO) and FDA review panel - the closest regulatory comparables to K921223.
HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-APTT
K924638 · International Technidyne Corp. · Jan 1993
STACLOT LA TEST KIT
K923731 · American Bioproducts Co. · Dec 1992
PLATELIN L
K921396 · Organon Teknika Corp. · Oct 1992
ACS APCT REAGENT
K921118 · Analytical Control Systems, Inc. · Jul 1992
ELLAGIC ACID APTT REAGENT
K915418 · Helena Laboratories · Feb 1992
HEMOCHRON ONESTEP APTT TEST
K915344 · International Technidyne Corp. · Feb 1992