Cleared Traditional

K873577 - GEM-STAT

K873577 is the FDA 510(k) clearance for GEM-STAT by Diamond Sensor Systems. It is a Class 2 Chemistry device (product code CHL) cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K873577 · Diamond Sensor Systems · Chemistry device
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Optimized for regulatory review, auditing and printing
Apr 1988
Decision
238d
Days
Class 2
Risk

K873577 is an FDA 510(k) clearance for the GEM-STAT, GEM-PAK 2, GEM-CHECK, GEM-CRIT CHECK. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Diamond Sensor Systems (Ann Arbor, US). The FDA issued a Cleared decision on April 28, 1988 after a review of 238 days - an extended review 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: 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 Diamond Sensor Systems devices

Submission Details

510(k) Number K873577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1987
Decision Date April 28, 1988
Days to Decision 238 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 88d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 131
Devices cleared under the same product code (CHL) and FDA review panel - the closest regulatory comparables to K873577.
IL1400, BGELECTROLYTE ANALYZER
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AVL MODEL 987 ELECTROLYTE ANALYZER
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NOVA STAT PROFILE 7 ANALYZER QUALITY CONTROL MATER
K884143 · Nova Biomedical Corp. · Dec 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
STAT PROFILE 4 ANALYZER + QUALITY CONTROL MATERIAL
K864445 · Nova Biomedical Corp. · Feb 1987