Cleared Traditional

K895119 - SYSTEMATE DIRECT BILIRUBIN CATALOG NO. ...

K895119 is the FDA 510(k) clearance for SYSTEMATE DIRECT BILIRUBIN CATALOG NO. ... by Em Diagnostic 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.

K895119 · Em Diagnostic Systems, Inc. · Chemistry device
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Oct 1989
Decision
63d
Days
Class 2
Risk

K895119 is an FDA 510(k) clearance for the SYSTEMATE DIRECT BILIRUBIN CATALOG 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 October 17, 1989 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K895119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1989
Decision Date October 17, 1989
Days to Decision 63 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
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 168
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K895119.
DIRECT BILIRUBIN REAGENT
K900259 · Medical Analysis Systems, Inc. · Feb 1990
TOTAL BILIRUBIN L.F.
K895822 · Sclavo, Inc. · Nov 1989
SYSTEMATE TOTAL BILIRUBIN CATALOG NO. 65407
K895118 · Em Diagnostic Systems, Inc. · Oct 1989
CLINISTAT TOTAL BILIRUBIN REAGENT TEST
K892801 · Heraeus Kulzer, Inc. · Aug 1989
DIRECT BILIRUBIN REAGENT
K893730 · Medical Analysis Systems, Inc. · Aug 1989
TOTAL BILIRUBIN FOR MANUAL/AUTOMATED APPLICATIONS
K892668 · Catachem, Inc. · Jul 1989