Cleared Traditional

K872818 - REFLOTRON BILIRUBIN

K872818 is an FDA 510(k) clearance for REFLOTRON BILIRUBIN, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Chemistry device with product code CIG cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K872818 · Boehringer Mannheim Corp. · Chemistry device
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Nov 1987
Decision
130d
Days
Class 2
Risk

K872818 is an FDA 510(k) clearance for the REFLOTRON BILIRUBIN. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on November 23, 1987 after a review of 130 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K872818

510(k) Number K872818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1987
Decision Date November 23, 1987
Days to Decision 130 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
42d slower than avg
Panel avg: 88d · This submission: 130d
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 178
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K872818.
DIRECT BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU.
K880397 · Data Medical Associates, Inc. · Mar 1988
BILIRUBIN (TOTAL)
K875069 · Tech-Co, Inc. · Jan 1988
IQ/QCA TOTAL BILIRUBIN
K874261 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1987
CONJUGATED BILIRUBIN (CBIL) ITEM NO. 67684/95
K873551 · Em Diagnostic Systems, Inc. · Oct 1987
EASY-TEST CONJUGATED BILIRUBIN (CBIL) #16690
K873424 · Em Diagnostic Systems, Inc. · Sep 1987
VISION(R) TOTAL BILIRUBIN
K872487 · Abbott Laboratories · Aug 1987