Cleared Traditional

K011972 - DIRECT BILIRUBIN REAGENT

K011972 is the FDA 510(k) clearance for DIRECT BILIRUBIN REAGENT by Intersect Systems, Inc.. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K011972 · Intersect Systems, Inc. · Chemistry device
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Aug 2001
Decision
63d
Days
Class 2
Risk

K011972 is an FDA 510(k) clearance for the DIRECT BILIRUBIN REAGENT. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Intersect Systems, Inc. (Longview, US). The FDA issued a Cleared decision on August 27, 2001 after a review of 63 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 Intersect Systems, Inc. devices

Submission Details

510(k) Number K011972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2001
Decision Date August 27, 2001
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 88d · This submission: 63d
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 173
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K011972.
BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30
K023330 · Diagnostic Chemicals , Ltd. · Dec 2002
TOTAL BILIRUBIN
K022339 · Abbott Laboratories · Sep 2002
DIRECT BILIRUBIN
K022180 · Abbott Laboratories · Sep 2002
BAYER ADVIA IMS SYSTEM
K993867 · Bayer Corp. · Apr 2000
MODIFICATION TO ALCYON DIRECT BILIRUBIN
K991175 · Abbott Laboratories · May 1999
TBIL
K983133 · Abbott Laboratories · Sep 1998