Cleared Traditional

K913249 - ACS ULTRA-1 THROMBOPLASTIN

K913249 is the FDA 510(k) clearance for ACS ULTRA-1 THROMBOPLASTIN by Analytical Control Systems, Inc.. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K913249 · Analytical Control Systems, Inc. · Hematology device
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Dec 1991
Decision
135d
Days
Class 2
Risk

K913249 is an FDA 510(k) clearance for the ACS ULTRA-1 THROMBOPLASTIN. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Analytical Control Systems, Inc. (Fishers, US). The FDA issued a Cleared decision on December 4, 1991 after a review of 135 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 Analytical Control Systems, Inc. devices

Submission Details

510(k) Number K913249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1991
Decision Date December 04, 1991
Days to Decision 135 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
22d slower than avg
Panel avg: 113d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 94
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K913249.
DADE RECOMBOPLASTIN S
K921326 · Baxter Diagnostics, Inc. · Jul 1992
NEOPLASTINE CI PLUS
K922040 · American Bioproducts Co. · Jun 1992
SIMPLASTIN L
K915746 · Organon Teknika Corp. · Feb 1992
ACS ULTRA-2 THROMBOPLASTIN
K913250 · Analytical Control Systems, Inc. · Nov 1991
ACS LIQUID THROMBOPLASTIN
K912102 · Analytical Control Systems, Inc. · Aug 1991
PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION
K911995 · International Technidyne Corp. · Jul 1991