Cleared Traditional

PT-MULTI-CALIBRATOR, MODEL OPAT07 (K093848) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K093848 · Dade Behring, Inc. · Hematology device
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Dec 2010
Decision
369d
Days
Class 2
Risk

K093848 is an FDA 510(k) clearance for the PT-MULTI-CALIBRATOR, MODEL OPAT07. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on December 20, 2010 after a review of 369 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - the FDA hematology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Dade Behring, Inc. devices

Submission Details

510(k) Number K093848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2009
Decision Date December 20, 2010
Days to Decision 369 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
256d slower than avg
Panel avg: 113d · This submission: 369d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGN Plasma, Coagulation Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 Hematology devices follow this clearance model.

Regulatory Peers - GGN Plasma, Coagulation Control

All 98
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K093848.
CONTROL PLASMA N, PROC CONTROL PLASMA
K042333 · Dade Behring, Inc. · Dec 2004
CONTROL PLASMA N AND CONTROL PLASMA P
K042209 · Dade Behring, Inc. · Oct 2004
HEPARINASE HR ACT CONTROL, MODEL 550-12
K042175 · Medtronic Vascular · Oct 2004
PURPLE/BLACK HEPARIN ASSAY CONTROL
K042206 · Medtronic Vascular · Oct 2004
DADE(R) PROTOTROL SYNTHETIC SUBSTRATE ASSAY CONTRO
K884901 · Baxter Healthcare Corp · Feb 1989