Cleared Traditional

K980041 - CARESIDE ALBUMIN

K980041 is an FDA 510(k) clearance for CARESIDE ALBUMIN, manufactured by Exigent Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CIX cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K980041 · Exigent Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
29d
Days
Class 2
Risk

K980041 is an FDA 510(k) clearance for the CARESIDE ALBUMIN. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Exigent Diagnostics, Inc. (Culver City, US). The FDA issued a Cleared decision on February 4, 1998 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1035 - 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 - K980041

510(k) Number K980041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1998
Decision Date February 04, 1998
Days to Decision 29 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
59d faster than avg
Panel avg: 88d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIX Device Classification - Class 2, Special Controls

Product Code CIX Bromcresol Green Dye-binding, Albumin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1035
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 - CIX Bromcresol Green Dye-binding, Albumin

All 105
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K980041.
RANDOX ALBUMIN
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ALBG
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ALBG
K981468 · Abbott Laboratories · May 1998
ALB OR ALBUMIN
K971445 · Carolina Liquid Chemistries Corp. · May 1997
ALBUMIN
K955781 · Derma Media Lab., Inc. · Mar 1996
TRACE COBAS MIRA RANGE
K952488 · Trace Scientific , Ltd. · Oct 1995