Cleared Traditional

K864445 - STAT PROFILE 4 ANALYZER + QUALITY CONTROL MATERIAL

K864445 is an FDA 510(k) clearance for STAT PROFILE 4 ANALYZER + QUALITY CONTR..., manufactured by Nova Biomedical Corp.. The device is a Class 2 Chemistry device with product code CHL cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K864445 · Nova Biomedical Corp. · Chemistry device
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Feb 1987
Decision
84d
Days
Class 2
Risk

K864445 is an FDA 510(k) clearance for the STAT PROFILE 4 ANALYZER + QUALITY CONTROL MATERIAL. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Nova Biomedical Corp. (Walham, US). The FDA issued a Cleared decision on February 4, 1987 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1120 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K864445

510(k) Number K864445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1986
Decision Date February 04, 1987
Days to Decision 84 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 88d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CHL Device Classification - Class 2, Special Controls

Product Code CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1120
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 - CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

All 178
Devices cleared under the same product code (CHL) and FDA review panel - the closest regulatory comparables to K864445.
GEM-STAT, GEM-PAK 2, GEM-CHECK, GEM-CRIT CHECK
K873577 · Diamond Sensor Systems · Apr 1988
ANALYZER: NOVA STAT PROFILE 3 ANALYZER
K871397 · Nova Biomedical Corp. · Jun 1987
CIBA CORNING MODEL 278 PH/BLOOD GAS SYSTEM
K865036 · Ciba Corning Diagnostics Corp. · Mar 1987
BLOOD GASES/ PO2, PCO2 AND BLOOD PH ANALYSIS PROD.
K863880 · D.R.G. Scientific Industries · Nov 1986
ABL330 ACID BASE LABORATORY
K860057 · Radiometer America, Inc. · Mar 1986
LIFE WATCH RESPIRATORY MONITOR
K853840 · The Perkin-Elmer Corp. · Dec 1985
K864445 · STAT PROFILE 4 ANALYZER + QUALITY CONTROL MATERIAL
Download PDF Nova Biomedical Corp.