Cleared Traditional

K012755 - AUTODIMER ASSAY MODEL # 1431

K012755 is an FDA 510(k) clearance for AUTODIMER ASSAY MODEL # 1431, manufactured by Xtrana, Inc.. The device is a Class 2 Hematology device with product code DAP cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K012755 · Xtrana, Inc. · Hematology device
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Mar 2002
Decision
211d
Days
Class 2
Risk

K012755 is an FDA 510(k) clearance for the AUTODIMER ASSAY MODEL # 1431. Classified as Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (product code DAP), Class II - Special Controls.

Submitted by Xtrana, Inc. (Ventura, US). The FDA issued a Cleared decision on March 15, 2002 after a review of 211 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7320 - 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. Standard predicate reliance. 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 Xtrana, Inc. devices

FDA 510(k) Submission Details - K012755

510(k) Number K012755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2001
Decision Date March 15, 2002
Days to Decision 211 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 113d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DAP Device Classification - Class 2, Special Controls

Product Code DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7320
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 - DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

All 52
Devices cleared under the same product code (DAP) and FDA review panel - the closest regulatory comparables to K012755.
STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D
K022976 · Dade Behring, Inc. · Jan 2003
STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C
K022977 · Dade Behring, Inc. · Nov 2002
VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442
K020810 · bioMerieux, Inc. · Oct 2002
SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
K013549 · Sigma Diagnostics, Inc. · Dec 2001
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
K013544 · Sigma Diagnostics, Inc. · Nov 2001
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
K013545 · Sigma Diagnostics, Inc. · Nov 2001