Cleared Traditional

K011128 - NICHOLS ADVANTAGE DIRECT RENIN (CALIBRA...

K011128 is the FDA 510(k) clearance for NICHOLS ADVANTAGE DIRECT RENIN (CALIBRA... by Nichols Institute Diagnostics. It is a Class 2 Chemistry device (product code CIB) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K011128 · Nichols Institute Diagnostics · Chemistry device
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Sep 2001
Decision
146d
Days
Class 2
Risk

K011128 is an FDA 510(k) clearance for the NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS,.... Classified as Radioimmunoassay, Angiotensin I And Renin (product code CIB), Class II - Special Controls.

Submitted by Nichols Institute Diagnostics (San Juan Capistrano, US). The FDA issued a Cleared decision on September 6, 2001 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1085 - 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 Nichols Institute Diagnostics devices

Submission Details

510(k) Number K011128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2001
Decision Date September 06, 2001
Days to Decision 146 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 88d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIB Radioimmunoassay, Angiotensin I And Renin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1085
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 - CIB Radioimmunoassay, Angiotensin I And Renin

Devices cleared under the same product code (CIB) and FDA review panel - the closest regulatory comparables to K011128.
LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT
K121944 · DiaSorin, Inc. · Jan 2013
ACTIVE RENIN IRMA
K061758 · Diagnostic Systems Laboratories, Inc. · Jul 2006
ACTIVE RENIN IRMA MODEL NUMBER DSL-25100
K981607 · Diagnostic Systems Laboratories, Inc. · May 1998
ACTIVE RENIN IMMUNORADIOMETRIC ASSAY
K925998 · Nichols Institute Diagnostics · Jan 1993
RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI
K850054 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1985
RENAK
K831694 · Hoffmann-La Roche, Inc. · Jul 1983