Cleared Special

ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY (K071587) - FDA 510(k) Clearance

Class I Chemistry device.

K071587 · Inverness Medical Innovations, Inc. · Chemistry device
Download Printable Device Report (PDF)
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Jul 2007
Decision
49d
Days
Class 1
Risk

K071587 is an FDA 510(k) clearance for the ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Inverness Medical Innovations, Inc. (Waltham, US). The FDA issued a Cleared decision on July 30, 2007 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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.

View all Inverness Medical Innovations, Inc. devices

Submission Details

510(k) Number K071587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2007
Decision Date July 30, 2007
Days to Decision 49 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 88d · This submission: 49d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJX Single (specified) Analyte Controls (assayed And Unassayed)

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