Cleared Traditional

K852008 - T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL

K852008 is an FDA 510(k) clearance for T-BIL REAGENT, manufactured by Alpkem Corp.. The device is a Class 2 Chemistry device with product code CIG cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K852008 · Alpkem Corp. · Chemistry device
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May 1985
Decision
23d
Days
Class 2
Risk

K852008 is an FDA 510(k) clearance for the T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Alpkem Corp. (Clackamas, US). The FDA issued a Cleared decision on May 30, 1985 after a review of 23 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 Alpkem Corp. devices

FDA 510(k) Submission Details - K852008

510(k) Number K852008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1985
Decision Date May 30, 1985
Days to Decision 23 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
65d faster than avg
Panel avg: 88d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIG Device Classification - Class 2, Special Controls

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 217
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K852008.
DIRECT BILIRUBIN
K860257 · Pointe Scientific, Inc., · Feb 1986
DIRECT & TOTAL BILIRUBIN SET
K855195 · Technostics Intl. · Jan 1986
IN-VITRO TEST DETERMINATION TOTAL BILIRUBIN
K854180 · Clinical Data, Inc. · Nov 1985
ABBOTT TDT EIA
K843908 · Abbott Laboratories · Apr 1985
DATA CHEM AUTO-BILIRUBIN/DIRECT PROCEDURE
K850901 · Data Medical Associates, Inc. · Apr 1985
DIRECT BILIRUBIN FOR DEMAND ANALYZER
K850379 · Advanced Biomedical Methods, Inc. · Mar 1985