Cleared Traditional

K885285 - DIRECT BILIRUBIN TEST CATALOG NO. SR1008

K885285 is the FDA 510(k) clearance for DIRECT BILIRUBIN TEST CATALOG NO. SR1008 by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K885285 · Em Diagnostic Systems, Inc. · Chemistry device
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Jan 1989
Decision
38d
Days
Class 2
Risk

K885285 is an FDA 510(k) clearance for the DIRECT BILIRUBIN TEST CATALOG NO. SR1008. 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 January 30, 1989 after a review of 38 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 K885285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1988
Decision Date January 30, 1989
Days to Decision 38 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
50d faster than avg
Panel avg: 88d · This submission: 38d
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 K885285.
TOTAL BILIRUBIN FOR CONTINUOUS FLOW
K891025 · Catachem, Inc. · Apr 1989
TOTAL BILIRUBIN REAGENT, CONCENTRATED
K890070 · Trace Scientific , Ltd. · Mar 1989
TOTAL BILIRUBIN TEST CATALOG NO. SR1007
K885284 · Em Diagnostic Systems, Inc. · Jan 1989
VISION(R) TOTAL BILIRUBIN WITH A NEONATAL CLAIM
K880437 · Abbott Laboratories · Aug 1988
BILIRUBIN (DIRECT)
K881172 · Tech-Co, Inc. · Jun 1988
TECHNICON CHEM 1(R) SYSTEM, DIRECT BILIRUBIN
K881798 · Technicon Instruments Corp. · Jun 1988