Cleared Traditional

K961908 - THOR HENOSTATSIS ANALYZER CAT. NO. 1450

K961908 is the FDA 510(k) clearance for THOR HENOSTATSIS ANALYZER CAT. NO. 1450 by Helena Laboratories. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K961908 · Helena Laboratories · Hematology device
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Dec 1996
Decision
208d
Days
Class 2
Risk

K961908 is an FDA 510(k) clearance for the THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on December 10, 1996 after a review of 208 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 Helena Laboratories devices

Submission Details

510(k) Number K961908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1996
Decision Date December 10, 1996
Days to Decision 208 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
95d slower than avg
Panel avg: 113d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 116
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K961908.
COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING
K974569 · Boehringer Mannheim Corp. · Jan 1998
CS-400 COAGULATION ANALYZER SYSTEM (A1208)
K972260 · Sigma Diagnostics, Inc. · Oct 1997
BEHRING COAGULATION SYSTEM
K970431 · Behring Diagnostics, Inc. · May 1997
KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)
K960875 · Sigma Diagnostics, Inc. · Sep 1996
AMAX CS-190 COAGULATION ANALYZER SYSTEM
K955720 · Sigma Diagnostics, Inc. · Mar 1996
KC 1A COAGULATION ANALYZER/SET
K955724 · Sigma Diagnostics, Inc. · Mar 1996