Cleared Traditional

K981183 - CARESIDE GLUCOSE

K981183 is an FDA 510(k) clearance for CARESIDE GLUCOSE, manufactured by Exigent Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K981183 · Exigent Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
36d
Days
Class 2
Risk

K981183 is an FDA 510(k) clearance for the CARESIDE GLUCOSE. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Exigent Diagnostics, Inc. (Culver City, US). The FDA issued a Cleared decision on May 7, 1998 after a review of 36 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 Exigent Diagnostics, Inc. devices

FDA 510(k) Submission Details - K981183

510(k) Number K981183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1998
Decision Date May 07, 1998
Days to Decision 36 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 88d · This submission: 36d
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 272
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