Cleared Special

K061758 - ACTIVE RENIN IRMA

K061758 is an FDA 510(k) clearance for ACTIVE RENIN IRMA, manufactured by Diagnostic Systems Laboratories, Inc.. The device is a Class 2 Chemistry device with product code CIB cleared through the Special 510(k) pathway after a 36-day FDA review.

K061758 · Diagnostic Systems Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
36d
Days
Class 2
Risk

K061758 is an FDA 510(k) clearance for the ACTIVE RENIN IRMA. Classified as Radioimmunoassay, Angiotensin I And Renin (product code CIB), Class II - Special Controls.

Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on July 28, 2006 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1085 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K061758

510(k) Number K061758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2006
Decision Date July 28, 2006
Days to Decision 36 days
Submission Type Special
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
53d faster than avg
Panel avg: 89d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

CIB Device Classification - Class 2, Special Controls

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

All 15
Devices cleared under the same product code (CIB) and FDA review panel - the closest regulatory comparables to K061758.
IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS
K123763 · Immunodiagnostic Systems , Ltd. · Dec 2013
LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT
K121944 · DiaSorin, Inc. · Jan 2013
CISBIO RENIN RIA TEST
K062120 · Cis Bio International · Mar 2007
NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)
K011128 · Nichols Institute Diagnostics · Sep 2001
ACTIVE RENIN IRMA MODEL NUMBER DSL-25100
K981607 · Diagnostic Systems Laboratories, Inc. · May 1998
BUHLMANN ANGIOSTENSIN II RIA
K954299 · Buhlmann Laboratories AG · Oct 1995
K061758 · ACTIVE RENIN IRMA
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