Cleared Traditional

CRIT-LINE ANEMIA MANAGEMENT SOFTWARE (K093834) - FDA 510(k) Clearance

Class I Microbiology device.

K093834 · Hema Metrics, LLC · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
289d
Days
Class 1
Risk

K093834 is an FDA 510(k) clearance for the CRIT-LINE ANEMIA MANAGEMENT SOFTWARE. Classified as Test, Urea (breath Or Blood) (product code MSQ), Class I - General Controls.

Submitted by Hema Metrics, LLC (Ogden, US). The FDA issued a Cleared decision on September 29, 2010 after a review of 289 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3110 - the FDA microbiology device 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hema Metrics, LLC devices

Submission Details

510(k) Number K093834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2009
Decision Date September 29, 2010
Days to Decision 289 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
187d slower than avg
Panel avg: 102d · This submission: 289d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MSQ Test, Urea (breath Or Blood)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3110
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 - MSQ Test, Urea (breath Or Blood)

All 16
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