Cleared Traditional

K980056 - CARESIDE ANALYZER

K980056 is an FDA 510(k) clearance for CARESIDE ANALYZER, manufactured by Exigent Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code JJF cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K980056 · Exigent Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
59d
Days
Class 1
Risk

K980056 is an FDA 510(k) clearance for the CARESIDE ANALYZER. Classified as Analyzer, Chemistry, Micro, For Clinical Use (product code JJF), Class I - General Controls.

Submitted by Exigent Diagnostics, Inc. (Culver City, US). The FDA issued a Cleared decision on March 6, 1998 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2170 - 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 - K980056

510(k) Number K980056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1998
Decision Date March 06, 1998
Days to Decision 59 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
29d faster than avg
Panel avg: 88d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

JJF Device Classification - Class 1, General Controls

Product Code JJF Analyzer, Chemistry, Micro, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2170
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJF Analyzer, Chemistry, Micro, For Clinical Use

All 43
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