Cleared Traditional

K873577 - GEM-STAT, GEM-PAK 2, GEM-CHECK, GEM-CRIT CHECK

K873577 is an FDA 510(k) clearance for GEM-STAT, manufactured by Diamond Sensor Systems. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K873577

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.

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 162
Devices cleared under the same product code (CHL) and FDA review panel - the closest regulatory comparables to K873577.
AVL MODEL 987 ELECTROLYTE ANALYZER
K891578 · Avl Scientific Corp. · May 1989
ELECTRODE A.PH BLOOD GAS B.ELECTROLYTE SYSTEMS
K884267 · Alko Diagnostic Corp. · May 1989
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