Cleared Traditional

K895407 - CORTISOL CLASP-BEAD EIA KIT

K895407 is the FDA 510(k) clearance for CORTISOL CLASP-BEAD EIA KIT by Biotecx Laboratories, Inc.. It is a Class 2 Chemistry device (product code CGR) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K895407 · Biotecx Laboratories, Inc. · Chemistry device
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Oct 1989
Decision
43d
Days
Class 2
Risk

K895407 is an FDA 510(k) clearance for the CORTISOL CLASP-BEAD EIA KIT. Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by Biotecx Laboratories, Inc. (Friendswood, US). The FDA issued a Cleared decision on October 19, 1989 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1205 - 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 Biotecx Laboratories, Inc. devices

Submission Details

510(k) Number K895407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1989
Decision Date October 19, 1989
Days to Decision 43 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 88d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGR Radioimmunoassay, Cortisol
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1205
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 - CGR Radioimmunoassay, Cortisol

All 47
Devices cleared under the same product code (CGR) and FDA review panel - the closest regulatory comparables to K895407.
CEDIA (TM) CORTISOL ASSAY
K901296 · Microgenics Corp. · Apr 1990
MODIFIED CEDIA(TM) CORTISOL ASSAY
K896451 · Microgenics Corp. · Dec 1989
MILENIA(TM) CORTISOL (MKCO1,5)
K895006 · Diagnostic Products Corp. · Oct 1989
DSL 7800 ACTIVE CORTISOL
K884689 · Diagnostic Systems Laboratories, Inc. · Feb 1989
CORTISOL ENHANCED LUMINESCENCE ASSAY KIT
K880687 · Amersham Corp. · Mar 1988
ACTIVE CORTISOL DSL 2000-SP
K850141 · Diagnostic Systems Laboratories, Inc. · Feb 1985