Cleared Traditional

K961908 - THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451

K961908 is an FDA 510(k) clearance for THOR HENOSTATSIS ANALYZER CAT. NO. 1450, manufactured by Helena Laboratories. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K961908

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.

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 K961908.
CS-400 COAGULATION ANALYZER SYSTEM (A1208)
K972260 · Sigma Diagnostics, Inc. · Oct 1997
BEHRING COAGULATION SYSTEM
K970431 · Behring Diagnostics, Inc. · May 1997
SYSMEX CA-1000/SYSMEX CA-5000
K964946 · Sysmex Corp. · Mar 1997
KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)
K960875 · Sigma Diagnostics, Inc. · Sep 1996
PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS
K954202 · Medtronic Hemotec, Inc. · Jun 1996
AMAX CS-190 COAGULATION ANALYZER SYSTEM
K955720 · Sigma Diagnostics, Inc. · Mar 1996