Cleared Traditional

K093834 - CRIT-LINE ANEMIA MANAGEMENT SOFTWARE

K093834 is an FDA 510(k) clearance for CRIT-LINE ANEMIA MANAGEMENT SOFTWARE, manufactured by Hema Metrics, LLC. The device is a Class 1 Microbiology device with product code MSQ cleared through the Traditional 510(k) pathway after a 289-day FDA review.

K093834 · Hema Metrics, LLC · Microbiology device
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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

FDA 510(k) Submission Details - K093834

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.

MSQ Device Classification - Class 1, General Controls

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 13
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