Cleared Traditional

K891480 - YSI MODEL 2300 STAT GLUCOSE AND L-LACTA...

K891480 is an FDA 510(k) clearance for YSI MODEL 2300 STAT GLUCOSE AND L-LACTA..., manufactured by Yellow Springs Instrument Co., Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K891480 · Yellow Springs Instrument Co., Inc. · Chemistry device
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May 1989
Decision
66d
Days
Class 2
Risk

K891480 is an FDA 510(k) clearance for the YSI MODEL 2300 STAT GLUCOSE AND L-LACTATE ANALYZER. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Yellow Springs Instrument Co., Inc. (Yellow Springs, US). The FDA issued a Cleared decision on May 22, 1989 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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.

View all Yellow Springs Instrument Co., Inc. devices

FDA 510(k) Submission Details - K891480

510(k) Number K891480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1989
Decision Date May 22, 1989
Days to Decision 66 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
22d faster than avg
Panel avg: 88d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGA Device Classification - Class 2, Special Controls

Product Code CGA Glucose Oxidase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 - CGA Glucose Oxidase, Glucose

All 231
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K891480.
FIRST CHOICE (TM)
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K893117 · Bayer Corp. · Jun 1989
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K892002 · American Monitor Corp. · Jun 1989
GLUCOFILM TEST STRIPS & CONTROLS/GLUCOMETER 3
K890873 · Heraeus Kulzer, Inc. · Apr 1989
ROCHE CHLORIDE ELECTRODE
K890528 · Roche Diagnostic Systems, Inc. · Mar 1989
GLUCOSE (GOD) REAGENT
K890336 · Alpkem Corp. · Feb 1989