Cleared Traditional

K011586 - IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE

K011586 is an FDA 510(k) clearance for IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE, manufactured by Diametrics Medical, Inc.. The device is a Class 1 Chemistry device with product code GAA cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K011586 · Diametrics Medical, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
177d
Days
Class 1
Risk

K011586 is an FDA 510(k) clearance for the IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Diametrics Medical, Inc. (Roseville, US). The FDA issued a Cleared decision on November 16, 2001 after a review of 177 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 878.4800 - 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 Diametrics Medical, Inc. devices

FDA 510(k) Submission Details - K011586

510(k) Number K011586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2001
Decision Date November 16, 2001
Days to Decision 177 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 88d · This submission: 177d
Pathway characteristics
Predicate-based equivalence.

GAA Device Classification - Class 1, General Controls

Product Code GAA Needle, Aspiration And Injection, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - GAA Needle, Aspiration And Injection, Disposable

All 73
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