Cleared Traditional

K843329 - SYSTEMATE D-BILI 67213

K843329 is an FDA 510(k) clearance for SYSTEMATE D-BILI 67213, 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 24-day FDA review.

K843329 · Em Diagnostic Systems, Inc. · Chemistry device
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Sep 1984
Decision
24d
Days
Class 2
Risk

K843329 is an FDA 510(k) clearance for the SYSTEMATE D-BILI 67213. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1984 after a review of 24 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

FDA 510(k) Submission Details - K843329

510(k) Number K843329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1984
Decision Date September 20, 1984
Days to Decision 24 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
64d faster than avg
Panel avg: 88d · This submission: 24d
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 K843329.
DATA CHEM AUTO-BILIRUBIN/DIRECT PROCEDURE
K850901 · Data Medical Associates, Inc. · Apr 1985
DIRECT BILIRUBIN FOR DEMAND ANALYZER
K850379 · Advanced Biomedical Methods, Inc. · Mar 1985
SYSTEMATE T-BILI 67212
K843328 · Em Diagnostic Systems, Inc. · Sep 1984
TOTAL BILIRUBIN TEST
K843178 · Sclavo, Inc. · Sep 1984
BILIRUBIN ASSAY KIT DIRECT
K843027 · Diagnostic Chemicals, Ltd. (Usa) · Sep 1984
BILIRUBIN ASSAY KIT - TOTAL
K843032 · Diagnostic Chemicals, Ltd. (Usa) · Sep 1984