Cleared Traditional

K012755 - AUTODIMER ASSAY MODEL # 1431

K012755 is the FDA 510(k) clearance for AUTODIMER ASSAY MODEL # 1431 by Xtrana, Inc.. It is a Class 2 Hematology device (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

Submission Details

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.

Device Classification

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 44
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