Cleared Traditional

K944325 - LIFESIGN

K944325 is an FDA 510(k) clearance for LIFESIGN, manufactured by Princeton BioMeditech Corp.. The device is a Class 2 Chemistry device with product code JHW cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K944325 · Princeton BioMeditech Corp. · Chemistry device
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Optimized for regulatory review, auditing and printing
Feb 1995
Decision
173d
Days
Class 2
Risk

K944325 is an FDA 510(k) clearance for the LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN. Classified as U.v. Method, Cpk Isoenzymes (product code JHW), Class II - Special Controls.

Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on February 22, 1995 after a review of 173 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Princeton BioMeditech Corp. devices

FDA 510(k) Submission Details - K944325

510(k) Number K944325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1994
Decision Date February 22, 1995
Days to Decision 173 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 88d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHW Device Classification - Class 2, Special Controls

Product Code JHW U.v. Method, Cpk Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1215
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 Chemistry devices follow this clearance model.

Regulatory Peers - JHW U.v. Method, Cpk Isoenzymes

All 20
Devices cleared under the same product code (JHW) and FDA review panel - the closest regulatory comparables to K944325.
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ELECSYS CK-MB
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K935924 · Abbott Laboratories · Jun 1994
CARDIO REP CK ISOENZYME KIT - 3310
K931050 · Helena Laboratories · Apr 1993
STAMBI-CK
K913349 · Intl. Immunoassay Laboratories, Inc. · Oct 1991