Cleared Traditional

TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS (K884224) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K884224 · A-Kem, Inc. · Chemistry device
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Dec 1988
Decision
70d
Days
Class 2
Risk

K884224 is an FDA 510(k) clearance for the TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by A-Kem, Inc. (Clifton, US). The FDA issued a Cleared decision on December 15, 1988 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1110 - 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 A-Kem, Inc. devices

Submission Details

510(k) Number K884224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1988
Decision Date December 15, 1988
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 88d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIG Diazo Colorimetry, Bilirubin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1110
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 - CIG Diazo Colorimetry, Bilirubin

All 68
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K884224.
SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406
K895119 · Em Diagnostic Systems, Inc. · Oct 1989
TOTAL BILIRUBIN TEST CATALOG NO. SR1007
K885284 · Em Diagnostic Systems, Inc. · Jan 1989
DIRECT BILIRUBIN TEST CATALOG NO. SR1008
K885285 · Em Diagnostic Systems, Inc. · Jan 1989
VISION(R) TOTAL BILIRUBIN WITH A NEONATAL CLAIM
K880437 · Abbott Laboratories · Aug 1988
ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT
K880743 · Abbott Laboratories · Apr 1988
IQ/QCA TOTAL BILIRUBIN
K874261 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1987