Cleared Traditional

K952488 - TRACE COBAS MIRA RANGE

K952488 is the FDA 510(k) clearance for TRACE COBAS MIRA RANGE by Trace Scientific , Ltd.. It is a Class 2 Chemistry device (product code CIX) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K952488 · Trace Scientific , Ltd. · Chemistry device
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Oct 1995
Decision
136d
Days
Class 2
Risk

K952488 is an FDA 510(k) clearance for the TRACE COBAS MIRA RANGE. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Trace Scientific , Ltd. (Miami, US). The FDA issued a Cleared decision on October 13, 1995 after a review of 136 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 Trace Scientific , Ltd. devices

Submission Details

510(k) Number K952488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1995
Decision Date October 13, 1995
Days to Decision 136 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
48d slower than avg
Panel avg: 88d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 77
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K952488.
RANDOX ALBUMIN
K984494 · Randox Laboratories, Ltd. · Mar 1999
ALBG
K981758 · Abbott Laboratories · Jun 1998
ALBG
K981468 · Abbott Laboratories · May 1998
DMA ALBUMIN PROCEDURE
K946355 · Data Medical Associates, Inc. · Mar 1995
EMDS ALBUMIN (ALB) TEST
K935179 · Em Diagnostic Systems, Inc. · Dec 1993
OLYMPUS ALBUMIN REAGENT
K924368 · Olympus Corp. · Feb 1993