Cleared Traditional

K932159 - SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406

K932159 is an FDA 510(k) clearance for SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406, manufactured by Em Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code CIG cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K932159 · Em Diagnostic Systems, Inc. · Chemistry device
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Sep 1993
Decision
140d
Days
Class 2
Risk

K932159 is an FDA 510(k) clearance for the SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on September 21, 1993 after a review of 140 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 Em Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K932159

510(k) Number K932159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1993
Decision Date September 21, 1993
Days to Decision 140 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 88d · This submission: 140d
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 215
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K932159.
BILIRUBIN (DIRECT) QVET
K942949 · Prisma Systems · Nov 1994
SYNERMED TOTAL BILIRUBIN REAGENT KIT
K940570 · Synermed, Inc. · Apr 1994
SYNERMED DIRECT BILIRUBIN REAGENT KIT
K933026 · Synermed, Inc. · Oct 1993
TOTAL BILIRUBIN
K931888 · Em Diagnostic Systems, Inc. · Jul 1993
OLYMPUS TOTAL BILIRUBIN REAGENT
K924964 · Olympus Corp. · Dec 1992
OLYMPUS DIRECT BILIRUBIN REAGENT
K924963 · Olympus Corp. · Nov 1992