Cleared Traditional

K921223 - ACS FREEZE-DRIED APTT REAGENT

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

K921223 · Analytical Control Systems, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 36
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