Cleared Traditional

K840757 - ELVI 444 BILITRON

K840757 is an FDA 510(k) clearance for ELVI 444 BILITRON, manufactured by Logos Scientific, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K840757

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.

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 218
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