Cleared Traditional

K925340 - COAGULATION CONTROL CONTAINING HEMOGLOBIN

K925340 is an FDA 510(k) clearance for COAGULATION CONTROL CONTAINING HEMOGLOBIN, manufactured by Analytical Control Systems, Inc.. The device is a Class 2 Hematology device with product code JPA cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K925340 · Analytical Control Systems, Inc. · Hematology device
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Mar 1993
Decision
154d
Days
Class 2
Risk

K925340 is an FDA 510(k) clearance for the COAGULATION CONTROL CONTAINING HEMOGLOBIN. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Analytical Control Systems, Inc. (Indianapolis, US). The FDA issued a Cleared decision on March 23, 1993 after a review of 154 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 Analytical Control Systems, Inc. devices

FDA 510(k) Submission Details - K925340

510(k) Number K925340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1992
Decision Date March 23, 1993
Days to Decision 154 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
41d slower than avg
Panel avg: 113d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPA Device Classification - Class 2, Special Controls

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
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 - JPA System, Multipurpose For In Vitro Coagulation Studies

All 158
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K925340.
DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI
K933188 · Baxter Diagnostics, Inc. · Sep 1993
BOEHRINGER MANNHEIM COAGUCHEK SYSTEM
K930454 · Boehringer Mannheim Corp. · Aug 1993
VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA
K930849 · Organon Teknika Corp. · Apr 1993
OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376
K926222 · Helena Laboratories · Feb 1993
ITC MICROSAMPLE COAGULATION ANALYZER SYSTEM
K923761 · International Technidyne Corp. · Jan 1993
CALCIUM CHLORIDE/DIETHYLBARB ACETATE BUFF SOLUTION
K924509 · Behring Diagnostics, Inc. · Dec 1992