Cleared Traditional

K923959 - ALBUMIN TEST

K923959 is an FDA 510(k) clearance for ALBUMIN TEST, manufactured by Em Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code CIX cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K923959 · Em Diagnostic Systems, Inc. · Chemistry device
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Dec 1992
Decision
144d
Days
Class 2
Risk

K923959 is an FDA 510(k) clearance for the ALBUMIN TEST. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on December 28, 1992 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1035 - 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 - K923959

510(k) Number K923959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1992
Decision Date December 28, 1992
Days to Decision 144 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
56d slower than avg
Panel avg: 88d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIX Device Classification - Class 2, Special Controls

Product Code CIX Bromcresol Green Dye-binding, Albumin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1035
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 - CIX Bromcresol Green Dye-binding, Albumin

All 106
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K923959.
ALBUMIN QVET
K943000 · Prisma Systems · Dec 1994
EMDS ALBUMIN (ALB) TEST
K935179 · Em Diagnostic Systems, Inc. · Dec 1993
OLYMPUS ALBUMIN REAGENT
K924368 · Olympus Corp. · Feb 1993
TRACE ALBUMIN-MR REAGENT
K923322 · Trace Scientific , Ltd. · Sep 1992
OLYMPUS ALBUMIN REAGENT
K922369 · Olympus Corp. · Jul 1992
TECHNICON CHEM 1(TM) SYST (GEN2 SYST)
K914888 · Technicon Instruments Corp. · Nov 1991