Cleared Traditional

K840757 - ELVI 444 BILITRON

K840757 is the FDA 510(k) clearance for ELVI 444 BILITRON by Logos Scientific, Inc.. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K840757 · Logos Scientific, Inc. · Chemistry device
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May 1984
Decision
97d
Days
Class 2
Risk

K840757 is an FDA 510(k) clearance for the ELVI 444 BILITRON. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Logos Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 30, 1984 after a review of 97 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 Logos Scientific, Inc. devices

Submission Details

510(k) Number K840757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1984
Decision Date May 30, 1984
Days to Decision 97 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 88d · This submission: 97d
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 K840757.
ACA CONJUGATED BILIRUBIN ANALYTICAL
K842385 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1984
TECHNICON RA-1000 SYS, DIRECT BILIRUBIN
K842809 · Technicon Instruments Corp. · Aug 1984
RAICHEM BILIRUBIN REAGENT TOTAL/DIRECT
K841892 · Reagents Applications, Inc. · Jun 1984
DIRECT BILIRUBIN REAGENT
K841572 · Hi Chem, Inc. · May 1984
TOTAL BILIRUBIN REAGENT SET
K841050 · Medical Specialties, Inc. · May 1984
EKTACHEM CLINICAL CHEM. SLIDES
K840880 · Eastman Kodak Company · Apr 1984