HEMOCLOT Quanti VL is an in vitro diagnostic test for the quantitative determination of Factor V Leiden (FVL) activity in human citrated plasma, using automated or manual methods, by its resistance to the action of Activated Protein C ( APC).

Patients with the Factor V-L (mutalion R506Q), are exposed to an increased thrombotic risk.

Biophen V-L CAL (undiluted), at defined Factor V-Leiden (FV-L) concentrations, for the callibration of Factor V-Leiden aclivity on human plasma, using the Hemoclot Quanti V-L kit.

Factor V-L Cafibrator, pre diluted (1:20) human plasmas. at defined Factor V-Leiden (FV-L) concentrations, for the calibration of Factor V-L activity on human plasma using Hemoclot Quanti V-L Kit.

Biophen Act PC-r Control Plasma contains human plasma, presenting an Activated Protein C Resistance (APC-R) is used as quality control plasma for the testing of Activated Protein C resistance (APC-R) on human plasma using Hemoclot Quarti V-L Kit.

(Updated) BIOPHEN Normal Control Plasma is a set of 12 vials of normal citrated human plasma for the quality control of some coagulation factors. The following table shows parameters, which are measured using assays from HYPHEN BioMed or from other manufacturers, and according to the package inserts:

Assays	Reagents	Manufacturers	Reference
ATIII	Biophen ATIII	Hyphen Biomed	221102/221105
Protein C	Biophen Protein C	Hyphen Biomed	221202/221205
aPC resistance(FV Leiden)	Hemoclot Quanti V-L	Hyphen Biomed	CK065K
LupusAnticoagulant	DVVtest®/DVVconfirm®	AmericanDiagnostica	810/815/815L

DVVtest, DVVconfirm are registered trademarks from American Diagnostica, Inc.

The BIOPHEN Normal Control Plasma is tested for the absence of Lupus Anticoagulant and can be used as a negative control for this investigation. This control plasma is also tested for the absence of Activated Protein C resistance (Act PC-7). When the APTT is performed with or without Activated Protein C (APC) the ratio obtained (APTT + APC/APTT) is ≥2.00.

Device Description

1. HEMOCLOT Quanti V-L is an in vitro diagnostic test kit containing 3 vials of each of the following 2 lyophilized reagents:
  R1: Reagent 1: Clotting mixture containing human Fibrinogen, human prothrombin, Protein S at a constant concentration, optimized for the assay, and human Activated Protein C, lyophilized. It also contains a heparin neutralizing substance. Each vial is to be reconstituted with exactly 2 ml of distilled water.

R2: Reagent 2: Purified Human Factor Xa, containing rabbit brain phospholipds (cephalin), lyophilized. Each vial is to be reconstituted with exactly 1 ml of distilled water.

Calibrators and controls to be used with the test kit are supplied separately. The following calibrators and control are included in this submission:

1. Factor V-L Calibrator is a calibrator kit containing 3 vials each of 1.0 ml prediluted human plasma (1:20), freeze dried, at 4 different concentrations of FV-L, to cover the assay range, from 10% to 100%. Each vial is restored with 1.0 ml Owren Koller type buffer.
1. BIOPHEN V-L CAL (Undiluted) is a calibrator kit containing 3 vials each of 0.5 ml undiluted human plasma, freeze dried, at 3 different concentrations of FV-L, to cover the assay range, from about 10% to 100%. Each vial is restored with 0.5 ml distilled water.
BIOPHEN Act PC-r Control Plasma is a controls kit containing 12 vials of 0.5 ml human 4. plasma, presenting an Activated Protein C Resistance (APC-R), citrated and Iyophilized. Each vial is to be reconstituted with exactly 0.5 ml of distilled water.
BIOPHEN Normal Control Plasma manufactured by Hyphen-Biomed, is also used with the test kit and is currently marketed in the US under 510(k) # K043451, It is a controls kit containing 12 vials of 1.0 ml of normal citrated human plasma, lyophilized. Each vial is to be reconstituted with exactly 1.0 ml of distilled water.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the HEMOCLOT Quanti V-L device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in terms of numerical thresholds for sensitivity, specificity, or agreement. Instead, it demonstrates consistency with a predicate device and molecular biology results. The performance is presented as direct agreement percentages.

Performance Metric	Acceptance Criteria (Implied/Demonstrated)	Reported Device Performance (HEMOCLOT Quanti V-L)
Agreement with Predicate Device (COATEST APCr)	To show "good consistency"	94.18%
Co-positivity with Predicate Device	To show "good consistency"	97.30%
Co-negativity with Predicate Device	To show "good consistency"	89.74%
Agreement with Molecular Biology	To show "good consistency" (ideally 100%)	100.00%
Co-positivity with Molecular Biology	To show "good consistency" (ideally 100%)	100.00%
Co-negativity with Molecular Biology	To show "good consistency" (ideally 100%)	100.00%
Intra-Assay CV (100% FVL plasma)	To demonstrate reproducibility	CT (sec): 4.4%, %FVL: 5.9%
Inter-Assay CV (100% FVL plasma)	To demonstrate reproducibility	CT (sec): 2.2%, %FVL: 3.3%
Intra-Assay CV (50% FVL plasma)	To demonstrate reproducibility	CT (sec): 4.2%, %FVL: 8.2%
Inter-Assay CV (50% FVL plasma)	To demonstrate reproducibility	CT (sec): 2.3%, %FVL: 4.7%
Inter-Assay CV (25% FVL plasma, KC10)	To demonstrate reproducibility	On CT (sec): 7.3%, On %FVL: 17.4%
Inter-Assay CV (10% FVL plasma, KC10)	To demonstrate reproducibility	On CT (sec): 6%, On %FVL: 29.1%
Inter-Assay CV (25% FVL plasma, STAR)	To demonstrate reproducibility	On CT (sec): 5.2%, On %FVL: 13.1%
Inter-Assay CV (10% FVL plasma, STAR)	To demonstrate reproducibility	On CT (sec): 5.6%, On %FVL: 23.7%
Inter-Assay CV (25% FVL plasma, WATER BATH)	To demonstrate reproducibility	On CT (sec): 2.7%, On %FVL: 10.0%
Inter-Assay CV (10% FVL plasma, WATER BATH)	To demonstrate reproducibility	On CT (sec): 5.6%, On %FVL: 15.2%

2. Sample Size Used for the Test Set and Data Provenance

Comparison with Predicate Device (COATEST APCr):
- Sample Size: 189 total samples (108 Normal, 70 Abnormal, 10 inconclusive/borderline based on detailed table analysis: 108 Normal + 1 Abnormal + 2 Inconclusive=111 from Predicate Normal; 7 Abnormal + 70 Abnormal + 1 Inconclusive = 78 from Predicate Abnormal). However, the "Sample Size" row explicitly states 189 for the overall comparison.
- Data Provenance: "combined from 4 studies (2 in US, 2 in Europe)." This indicates a retrospective or prospective collection across multiple sites. The specific nature (retrospective/prospective) is not explicitly stated, but clinical studies often involve a mix.
Comparison with Molecular Biology:
- Sample Size: 21 total samples (15 Normal, 6 Abnormal).
- Data Provenance: Not explicitly stated, but implied to be part of the overall validation studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of "experts" for establishing ground truth in the traditional sense of clinical readings.

For the comparison with the predicate device, the "ground truth" for the test set was the classification (Normal/Abnormal) provided by the COATEST APCr kit. This is a laboratory diagnostic assay, not an expert human interpretation.
For the comparison with Molecular Biology, the "ground truth" was the molecular biology result itself (indicating presence or absence of the R506Q mutation). This is an objective genetic test, not subject to expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. As the ground truth was established by another diagnostic assay (COATEST APCr) or molecular biology, there was no human adjudication process involved. The results were compared against these established methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This study is for an in vitro diagnostic (IVD) assay, which measures an analytical marker in human plasma. It does not involve human readers interpreting images or data, so an MRMC study comparing human readers with and without AI assistance is not relevant or applicable here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, this entire study represents the standalone performance of the HEMOCLOT Quanti V-L device. It evaluates the device's ability to classify samples as Normal, Abnormal, or Inconclusive based on its own measurements, compared against a predicate device and a molecular biology reference. There is no human interpretation involved in the direct result generation of the HEMOCLOT Quanti V-L assay itself.

7. The Type of Ground Truth Used

Comparison with Predicate Device: The ground truth was the result obtained from the COATEST APC Resistance V (K963111) predicate device.
Comparison with Molecular Biology: The ground truth was the molecular biology result for the Factor V Leiden (mutation R506Q). This is pathology/genetic testing data, considered a highly objective measure for the presence of the mutation.

8. The Sample Size for the Training Set

The document doesn't explicitly mention a separate "training set" for the HEMOCLOT Quanti V-L assay in the context of machine learning or AI. For IVD kits like this, the "training" typically refers to the optimization and validation performed by the manufacturer during product development, using various samples to establish assay parameters, linearity, sensitivity, specificity, and reproducibility. The performance data presented here is the validation or "test" set used to demonstrate substantial equivalence.

9. How the Ground Truth for the Training Set Was Established

As there's no mention of a traditional machine learning "training set" with separate ground truth establishment, this question is not fully applicable in the context of this document. For IVD development, the "ground truth" for calibrators, controls, and method development would have been established through highly characterized reference materials, potentially confirmed by molecular methods or established clinical diagnoses of FVL status.

Summary

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— 8 2009

Premarket Notification 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:	K08 3729
Submitted by:	Aniara Diagnostica, LLC6560 Gove CtMason, Ohio 45040
Contact Person:	Mr. Ola Andersson
Phone Number:	(513) 770-1979
Fax Number:	(513) 573-9241
Email address:	Ola@aniara.com
Date of 510(k) Preparation:	December, 2008
Name of the Devices:	1. HEMOCLOT Quanti V-L2. Factor V-L Calibrator3. BIOPHEN V-L CAL (Undiluted)4. BIOPHEN Act PC-r Control Plasma
Classification Name:	Test, Partial Thrombin TimeSecondary CalibratorCoagulation Control Plasma
Class:	II
Classification Panels:	Hematology (81)
Product Code:	GGW, Test, Partial Thrombin TimeJIT, Calibrator, SecondaryGGN, Plasma, Coagulation Control
Regulation numbers:	864.7925862.1150864.5425
Identification of the Predicate Device:

COATEST APC Resistance V (K963111) (Chromogenix)

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Description of the Device:

[All devices are manufactured by Hyphen-Biomed]

1. HEMOCLOT Quanti V-L is an in vitro diagnostic test kit containing 3 vials of each of the following 2 lyophilized reagents:
  R1: Reagent 1: Clotting mixture containing human Fibrinogen, human prothrombin, Protein S at a constant concentration, optimized for the assay, and human Activated Protein C, lyophilized. It also contains a heparin neutralizing substance. Each vial is to be reconstituted with exactly 2 ml of distilled water.

R2: Reagent 2: Purified Human Factor Xa, containing rabbit brain phospholipds (cephalin), lyophilized. Each vial is to be reconstituted with exactly 1 ml of distilled water.

Calibrators and controls to be used with the test kit are supplied separately. The following calibrators and control are included in this submission:

1. Factor V-L Calibrator is a calibrator kit containing 3 vials each of 1.0 ml prediluted human plasma (1:20), freeze dried, at 4 different concentrations of FV-L, to cover the assay range, from 10% to 100%. Each vial is restored with 1.0 ml Owren Koller type buffer.
1. BIOPHEN V-L CAL (Undiluted) is a calibrator kit containing 3 vials each of 0.5 ml undiluted human plasma, freeze dried, at 3 different concentrations of FV-L, to cover the assay range, from about 10% to 100%. Each vial is restored with 0.5 ml distilled water.
BIOPHEN Act PC-r Control Plasma is a controls kit containing 12 vials of 0.5 ml human 4. plasma, presenting an Activated Protein C Resistance (APC-R), citrated and Iyophilized. Each vial is to be reconstituted with exactly 0.5 ml of distilled water.
BIOPHEN Normal Control Plasma manufactured by Hyphen-Biomed, is also used with the ട് test kit and is currently marketed in the US under 510(k) # K043451, It is a controls kit containing 12 vials of 1.0 ml of normal citrated human plasma, lyophilized. Each vial is to be reconstituted with exactly 1.0 ml of distilled water.

Intended Use:

1. HEMOCLOT Quanti V-L is a clotling method for measuring the Factor V Leiden (FVL) activity in human citrated plasma, by its resistance to the action of Activated Protein C (APC). The assay is performed in the presence of Activated Protein S (one single test for each patient). In the presence of APC, the prolongation of clotting time is an inverse relationship of the concentration of Factor V-Leiden (mutation R506Q). Normal Factor V is not measured.
1. Factor V-L Calibrator is Iyophilized, pre-diluted (1:20) human plasmas, at defined Factor V-Leiden (FV-L) concentrations, for the calibration of Factor V-L activity quantitative clotting assay on human citrated plasma, using the HEMOCLOT Quanti. V-L Kit (ref CK065K).
BIOPHEN V-L CAL (Undiluted) is Iyophilized, undiluted human plasmas, at defined Factor V-3. Leiden (FV-L) concentrations for the calibration curve of Factor V-L activity quantitative clotting assay on human citrated plasma, using HEMOCLOT Quanti V-L Kit (ref CK065K).
1. BIOPHEN Act PC-r Control Plasma kit contains human plasma, presenting an activated Protein C Resistance (APC-R), usually correlated with the genetic mutation of Factor V

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R506Q. This plasma is used as quality control plasma for the testing of Activated Protein C Resistance (APC-R).

1. (Updated) BIOPHEN Normal Control Plasma is a set of 12 vials of normal citrated human plasma for the quality control of some coagulation factors. The following table shows the various parameters, which are measured using assays from HYPHEN BioMed or from other manufacturers, and according to the package inserts:

Assays	Reagents	Manufacturers	Reference
ATIII	Biophen ATIII	Hyphen Biomed	221102/221105
Protein C	Biophen Protein C	Hyphen Biomed	221202/221205
aPC resistance (FV Leiden)	Hemoclot Quanti V-L	Hyphen Biomed	CK065K
LupusAnticoagulant	DVVtest®/DVVconfirm®	AmericanDiagnostica	810/815/815L

DVVtest, DVVconfirm are registered trade marks from American Diagnostica, Inc.

The BIOPHEN Normal Control Plasma is tested for the absence of Lupus Anticoagulant and can be used as a negative control for this investigation. This control plasma is also tested for the absence of Activated Protein C resistance (Act PC-r). When the APTT is performed with or without Activated Protein C (APC) the ratio obtained (APTT + APC/APTT) is ≥ 2.00.

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Statement of Technological Characteristics of the Device Compared to Predicate Device:

HEMOCLOT Quanti V-L, BIOPHEN V-L CAL (Undiluted), Factor V-L Calibrator, BIOPHEN Act PC-r Control Plasma, and BIOPHEN Normal Control Plasma are substantially equivalent in performance, intended use and safety and effectiveness to COATEST APC Resistance V (K963111).

Characteristics	HEMOCLOT Quanti V-L, FactorV-L Calibrator, Biophen V-LCAL (undiluted), Biophen ActPC-r Control Plasma, BiophenNormal Control Plasma	COATEST APC Resistance V(K963111). Control Plasmas Level 1and Level 2 are included in thisdevice.
Similarities
Intended Use	Measurement of Factor V Leidenactivity in human citrated plasmaby its resistance to the action ofActivated Protein C.	Same
Assay Type	Clotting Method	Same
Test Sample	Human Citrated Plasma	Same
Assay Principle	Measurement of Factor V Leidencoagulation activity based oninsensitivity of Factor V Leiden tothe action of Activated Protein C.	Same
Stability ofUnopenedReagents	Stable at 2-8°C until expiry date	Same
Controls,Normal	Citrated human plasma,lyophilized, to provide qualitycontrol in the normal range. APC VRatio > 2	Same
Controls,Abnormal (APCResistant)	Citrated human plasma,lyophilized, to provide qualitycontrol for APC resistant range ofthe assay. APC V Ratio < 1.80	Same.
Differences
Assay Principle	Assay is performed in thepresence of Activated Protein Cand Protein S (one single test foreach patient). In the presence ofAPC, prolongation of clotting timeis inversely related to the amountof Factor V Leiden. Normal FactorV is not measured. APCresistance due to Factor V Leidenis indicated when the %FVL valueis above or equal to the cut-offvalue.	Assay is performed in the presenceand absence of Activated Protein C(two tests for each patient). In thepresence of APC, prolongation ofclotting time is directly related to theconcentration of Normal Factor V, andinversely related to the amount ofFactor V Leiden. APC resistance duethe APC-V ratio is below or equal tothe cut-off value.
AssayCalibration	Assay of calibrator plasma atdefined Factor V Leiden	Not Applicable

	available in prediluted (FVLCalibrator) and undiluted(BIOPHEN V-L Cal) form,lyophilized.
Cut-Off Values	Normal plasmas measure ≤10%FVL. APCr plasmas measure>25% FVL.	Normal cut-off value (ratio) determinedby assay of normal patient plasmasand statistical analysis of the results.
Test SampleDilution	Test sample diluted in OwrenKoller type buffer (not included inkit).	Test sample diluted with V-Def Plasma(included in kit).
Controls,Normal	Biophen Normal Control Plasmasold separately from kit.	Control Plasma Level 1 included in kit.
Controls,Abnormal (APCResistant)	Biophen Act. PC-r Control Plasmasold separately from kit.	Control Plasma Level 2 included in kit.
Controls,Normal &Abnormal (APCResistant)	%FVL < 10% (Normal Control);%FVL between 25% and 75%(APCr Control)	Value of APC-R provided as ratio only.
Stability ofReconstitutedReagents	R1 and R2 reagents: 24 hrs at 2-8°C;12 hrs at 18-25°C; 1 monthfrozen at -20°C or below.Control Plasmas and Calibrators:8 hrs at room temperature; 24h at2-8°C; Do Not Freeze.	When stored in original vials: V-DefPlasma: 8 hrs at 15-25°C; 24 hrs at 2-8°C; 3 months at -20°C or below.CaCl₂ and APTT reagent: 1 month at2-8°C; 1 week at 15-25°C. APC/CaCl₂reagent: 2 hrs at 37°C; 8 hrs at 15-25°C; 5 days at 2-8°C; 3 months at -20°Cor below. Control Plasmas: 6 hrs at 2-25°C or 3 months at -20°C or below.

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Aniara Diagnostica, LLC
Premarket Notification Section 510(k)
Hemoclot Quanti V-L; Factor V-L Calibrator: Biophen V-L Calibrator: Biophen V-L Calibration Actives: A Controlle

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Summary of Performance Data:

Hemoclot Quanti V-L

The HEMOCLOT Quanti V-L (Hyphen-Biomed) assay shows good consistency with Coatest APCr kit (Chromogenix), as shown from data combined from 4 studies (2 in US, 2 in Europe):

All Sites		Coatest APCr
		Normal	Abnormal
HemoclotQuanti V-L	Normal	108	7
	Abnormal	1	70
	Inconclusive*	2	1
Agreement		94.18%
Co-positivity		97.30%
Co-negativity		89.74%
Sample Size		189

*Outside of the range of the assay, between 10% and 25% FVL.

The Hemoclot Quanti VL Assay shows good consistency with Molecular Biology results:

		MolecularBiology
		Normal	Abnormal.
Hemoclot	Normal	15	0
FVL-Q	Abnormal	0	6
Agreement		100.00%
Co-positivity		100.00%
Co-negativity		100.00%
Sample Size		21

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Reproducibility of the Hemoclot Quanti V-L assay for 2 plasmas at different FVL concentrations, using the KC10, STAR or Water Bath instrument:

Sample	Intra Assay CV%			Inter Assay CV%
	CT (sec)	%FVL	N	CT (sec)	%FVL	N
Sample 1 (100% FVL)	4.4%	5.9%	10	2.2%	3.3%	10
Sample 2 (50% FVL)	4.2%	8.2%	10	2.3%	4.7%	10

Instrument	Sample	Inter Assay CV%
		On CT (sec)	On %FVL	N
KC10	Sample 1 (25% FVL)	7.3%	17.4%	5
	Sample 2 (10% FVL)	6%	29.1%	5
STAR	Sample 1 (25% FVL)	5.2%	13.1%	10
	Sample 2 (10% FVL)	5.6%	23.7%	10
WATER BATH	Sample 1 (25% FVL)	2.7%	10.0%	5
	Sample 2 (10% FVL)	5.6%	15.2%	5

Conclusion:

The performance studies demonstrate that the device is substantially equivalent to the predicate device in safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY -8 2009

Aniara Diagnostica, LLC c/o Ms. Ola Anderson 6560 Gove Ct. Mason, OH 45040

Re: K083729

Trade/Device Name: HEMOCLOT Quanti V-L, Factor V-L Calibrator, Biophen V-L Cal (Undiluted), Biophen ACT PC-r Control Plasma and Biophen Normal Control

Regulation Number: 21 CFR 864.7925 Regulation Name: Partial thromboplastin time tests Regulatory Class: Class II Product Code: GGW, GGN, JIT Dated: April 07, 2009 Received: April 20, 2009

Dear Ms. Anderson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice

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Page 2 - Ms. Ola Anderson

requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

m. Chen

Maria M. Chan, PhD Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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K083729

Indications for Use

Patients with the Factor V-L (mutalion R506Q), are exposed to an increased thrombotic risk.

Biophen V-L CAL (undilated), at defined Factor V-Leiden (FV-L) concentrations, for the callibration of Factor V-Leiden aclivity on human plasma, using the Hemoclot Quanti V-L kit.

Factor V-L Cafibrator, pre diluted (1:20) human plasmas. at defined Factor V-Leiden (FV-L) concentrations, for the calibration of Factor V-L activity on human plasma using Hemoclot Quanti V-L Kit.

Assays	Reagents	Manufacturers	Reference
ATIII	Biophen ATIII	Hyphen Biomed	221102/221105
Protein C	Biophen Protein C	Hyphen Biomed	221202/221205
aPC resistance(FV Leiden)	Hemoclot Quanti V-L	Hyphen Biomed	CK065K
LupusAnticoagulant	DVVtest®/DVVconfirm®	AmericanDiagnostica	810/815/815L

DVVtest, DVVconfirm are registered trademarks from American Diagnostica, Inc.

Demellax

Division Sign-Off

Office of In Vitro Diagnostic
Device Evaluation and Safety

510(k) K083729

Regulation Number and Section

§ 864.7925 Partial thromboplastin time tests.

(a)
Identification. A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.(b)
Classification. Class II (performance standards).