Cleared Traditional

K010790 - CORTISOL LIA

K010790 is an FDA 510(k) clearance for CORTISOL LIA, manufactured by Kmi Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CGR cleared through the Traditional 510(k) pathway after a 320-day FDA review.

K010790 · Kmi Diagnostics, Inc. · Chemistry device
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Jan 2002
Decision
320d
Days
Class 2
Risk

K010790 is an FDA 510(k) clearance for the CORTISOL LIA. Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by Kmi Diagnostics, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 29, 2002 after a review of 320 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Kmi Diagnostics, Inc. devices

FDA 510(k) Submission Details - K010790

510(k) Number K010790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2001
Decision Date January 29, 2002
Days to Decision 320 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
232d slower than avg
Panel avg: 88d · This submission: 320d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGR Device Classification - Class 2, Special Controls

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 59
Devices cleared under the same product code (CGR) and FDA review panel - the closest regulatory comparables to K010790.
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS
K060480 · Ortho-Clinical Diagnostics · Jul 2006
CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
K050202 · Beckman Coulter, Inc. · Feb 2005
NICHOLS ADVANTAGE CORTISOL
K042689 · Nichols Institute Diagnostics · Dec 2004
NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005
K984520 · Nichols Institute Diagnostics · Feb 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY
K983990 · Ortho-Clinical Diagnostics, Inc. · Dec 1998
NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT
K962208 · Nichols Institute Diagnostics · Apr 1997