LupoTek Detectin VL and Correctin VL test kits are qualitative tests intended to aid in the detection of lupus anticoagulants (LA) in citrated human plasma by the dilute Russell's viper venom method in professional clinical laboratories.

PlasmaCon LA is intended for use as an LA positive, abnormal quality control plasma to monitor the performance of diagnostic assays, performed in professional clinical laboratories, for the presence of lupus anticoagulants in citrated plasma.

Device Description

LupoTek Detectin VL and LupoTek Correctin VL use Vipera lebetina venom rather than Vipera russelli (Russell's Viper) venom in the dRVVT assay for lupus anticoagulant. Vipera lebetina venom, like Russell's viper venom, will directly activate Factor X without requiring Factor VII. The activated Factor X in conjunction with Factors V, II, calcium ions and phospholipid will generate thrombin which converts fibrinogen to fibrin, producing a clot in the test system. LupoTek Detectin VL, the low phospholipid reagent, is designed as the screening reagent to detect a prolongation of the clotting time. LupoTek Correctin VL is the high phospholipid reagent that neutralizes the LA and corrects the clotting time to normal, confirming the presence of a Lupus Anticoagulant.

PlasmaCon LA is a lyophilized Lupus Anticoagulant (LA) positive plasma suitable for use as a quality control plasma for in vitro diagnostic assays in the clinical coagulation laboratory sensitive for the presence of LA

AI/ML Overview

The provided text describes the LupoTek Detectin VL, LupoTek Correctin VL, and PlasmaCon LA devices, which are related to the detection of lupus anticoagulants (LA).

Here's an analysis of the acceptance criteria and the study as described in the text:

1. Table of Acceptance Criteria and Reported Device Performance

The text does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for positive or negative agreement percentages. Instead, it presents the results of a comparative study to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion is likely to be a high level of agreement with the predicate devices.

Metric	Acceptance Criteria (Implicit)	Reported Device Performance (LupoTek Detectin VL / Correctin VL)
Percent Positive Agreement	High agreement with predicate	98%
Percent Negative Agreement	High agreement with predicate	96%

For PlasmaCon LA, the text states it is for use as an LA positive, abnormal quality control plasma to monitor diagnostic assays. Its performance is compared to a predicate device (American Diagnostica LAtrol Abnormal Control) based on similarities in intended use, constituent material, measurement principle, format, and analyte. Specific performance metrics like agreement percentages are not provided for PlasmaCon LA itself, as its role is a control.

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

Sample Size for LupoTek Detectin VL / Correctin VL: 155 patient samples.
Data Provenance: The text states "three sites" were used for analysis, indicating a multi-center study. The country of origin is not specified, nor is whether the data was retrospective or prospective.

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

The text does not provide information on the number of experts used or their qualifications to establish ground truth. It implies that the predicate device's results (Stago DRVV Screen / Confirm kits) served as the reference standard for comparison.

4. Adjudication Method for the Test Set

The text does not specify any adjudication method. It describes a comparison between the investigational device and predicate devices.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. The described study compares the device's performance to a predicate device, not the improvement of human readers with or without AI assistance. The devices in question are diagnostic reagents, not AI-based image analysis tools or decision support systems.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was done. The described study evaluates the performance of the LupoTek Detectin VL / Correctin VL kits themselves in detecting lupus anticoagulants in patient samples by comparing their results directly to those of the predicate devices. There is no mention of human-in-the-loop performance in this context.

7. Type of Ground Truth Used

The ground truth was established by the results obtained from the predicate devices (Stago DRVV Screen / Confirm kits). This is a form of comparative effectiveness or reference standard based on an already marketed and accepted diagnostic method.

8. Sample Size for the Training Set

The text does not mention a training set in the context of device development or performance evaluation. This type of diagnostic reagent typically undergoes initial development and validation, but the reported study is a performance comparison for regulatory submission, not machine learning model training.

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

As no training set is mentioned for the reported study, this information is not applicable/provided.

Summary

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510(k) Summary

This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K083878.

1) Applicant Name and Address

JUN 2 5 2010

Applicant:	r2 Diagnostics, Inc.
Address:	1801 Commerce Drive
	South Bend, IN 46628
Contact Person:	Marc D. Goldford
Phone #:	574-288-4377
Fax #:	574-288-2272
Email:	marc@r2diagnostics.com
Date of Preparation:	23 Jun 2010

2) Device Name(s)

Trade Name:	LupoTek Detectin VLLupoTek Correctin VL
Classification Name:	Reagent, Russell Viper Venom (21CFR 864.8950, Product Code GIR)

Trade Name: PlasmaCon LA Classification Name: Abnormal control plasma (21CFR 864.5425, Product Code GGC)

3) Predicate Device(s)

LupoTek Detectin VL: Diagnostica Stago DRVV Screen (K061805) LupoTek Correctin VL: Diagnostica Stago DRVV Confirm (K061805) PlasmaCon LA: American Diagnostica LAtrol Abnormal Control (K935254)

4) Device Description(s)

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5) Intended Use(s)

6) Technological Characteristic Summary

The in vitro diagnostics device(s) presented in this 510(k) submission, LupoTek Detectin VL. LupoTek Correctin VL. and PlasmaCon LA are substantially equivalent, respectively, to the Stago DRVV Screen, Stago DRVV Confirm, and American Diagnostica LAtrol Abnormal Control in vitro diagnostics devices.

One hundred fifty-five patient samples with various clinical conditions including LA were analyzed in three sites with the LupoTek Detectin VL / Correctin VL and the Stago DRVV Screen / Confirm kits. The percent positive agreement was 98% and the percent negative agreement was 96%.

Comparisons of the submitted kits and their respective predicate kits are summarized in the tables below:

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Table 1: Comparison of submitted devices LupoTek Detectin VL and Correctin VL to
predicate device Stago DRVV Screen and Confirm
	Similarities
Item	Submitted Device	Predicate Device
Intended use	LupoTek DetecTin VL andCorrecTin VL test kits arequalitative tests intended to aidin the detection of lupusanticoagulants (LA) in citratedhuman plasma by the diluteRussell's viper venom methodin professional clinicallaboratories.	The STA Staclot dRVV Screenand STA Staclot dRVV Confirmkits are intended for thedetection of the lupusanticoagulants(LA) in plasmaby the dilute Russell's vipervenom test (1) performed withanalyzers of the STA linesuitable to these reagents.
Patient sample	Citrated human plasma	Citrated human plasma
Measurementprinciple	Vipera lebetina venom, likeRussell's viper venom, willdirectly activate Factor Xwithout requiring Factor VII.The activated Factor X inconjunction with Factors V, II,calcium ions and phospholipidwill generate thrombin whichconverts fibrinogen to fibrin,producing a clot in the testsystem.The LupoTek DetecTin VL isdesigned as the screeningreagent to detect a prolongationof the clotting time. TheLupoTek CorrecTin VL is ahigh phospholipid reagent thatneutralizes the LA and correctsthe clotting time to normal,confirming the presence of aLupus Anticoagulant.	Lupus anticoagulants areantibodies directed againstphospholipid/protein complexes.Staclot® dRVV Screen test isperformed with a lowphospholipids concentrationreagent to screen samples. Iflupus anticoagulants are present,the clotting time willbe prolonged.The Staclot® dRVV ConfirmReagent contains a higherphospholipids concentrationto neutralize the LA present inthe plasma to be tested. Theclotting time obtainedwith the Staclot® dRVVConfirm Reagent will be shorterthan the one observed withthe Staclot® dRVV Screenreagent.
Format	Lyophilized reagents consistingof venom, phospholipid,anti-heparin agent, calcium,buffers, stabilizers, and a dye.	Lyophilized reagents consistingof venom, phospholipid,anti-heparin agent, calcium,buffers, and stabilizers.
Analyte	Lupus anticoagulants	Lupus anticoagulants
	Differences
Item	Submitted Device	Predicate Device
Venom source	Vipera lebetina	Vipera russelli
Color	Detectin VL: BlueCorrectin VL: Pink	Screen: GreenConfirm: Light Orange
ReconstitutedStability	2-8C: 24 hrRT: 8 hr	2-8C: not listedRT: not listed

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Table 2: Comparison of submitted device PlasmaCon LA topredicate device American Diagnostica LAtrol Abnormal Control
Similarities
Item	Submitted Device	Predicate Device
Intended use	PlasmaCon LA is intended for use as an LA positive, abnormal quality control plasma to monitor the performance of diagnostic assays, performed in professional clinical laboratories, for the presence of Lupus Anticoagulants (LA) in citrated human plasma.	The LAtrol Abnormal control and LAtrol Normal control plasmas have been developed for use as part of daily quality control procedures for Lupus Anticoagulant (LA) testing.
Constituent material	Citrated human plasma positive for Lupus Anticoagulant(s).	Citrated human plasma positive for Lupus Anticoagulant(s).
Measurement principle	The Lupus Anticoagulant(s) in the abnormal control plasma lengthen the clotting times of LA sensitive diagnostic assays.	The Lupus Anticoagulant(s) in the abnormal control plasma lengthen the clotting times of LA sensitive diagnostic assays.
Format	Lyophilized plasma	Lyophilized plasma
Analyte being tested	Lupus anticoagulants	Lupus anticoagulants
Differences
Item	Submitted Device	Predicate Device
Reconstituted Stability	2-8C: 8 hrRT: 4 hr	2-8C: 8 hr(RT: not listed)

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle emblem, with three curved lines representing the eagle's body and wings. The emblem is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center-WO66-G609 Silver Spring, MD 20993-0002

R2 Diagnostics c/o Mr. Marc D. Goldford Director, Research and Development 1801 Commerce Drive South Bend, IN 46628

Re: K083878

Trade/Device Name: LupoTek DetecTin VL LupoTek CorrecTin VL PlasmaCon LA Regulation Number: 21 CFR §864.8950 Regulation Name: Russell viper venom reagent Regulatory Class: Class II Product Code: GIR, GGC Dated: April 21, 2010 Received: April 22, 2010

JUN 2 5 2010

Dear Mr. Goldford:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), 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 requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter

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Page 2 - Mr. Marc Goldford

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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Maria McChan

Maria M. Chan. Ph.D 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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Indication for Use

510(k) Number (if known): K083878

Device Name: PlasmaCon LA

Indication For Use: PlasmaCon LA is intended for use as an LA positive, abnormal quality control plasma to monitor the performance of diagnostic assays, performed in professional clinical laboratories, for the presence of lupus anticoagulants in citrated plasma.

Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

. .

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Seach R.K.

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K083878

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Indication for Use

510(k) Number (if known): K083878

Device Names: LupoTek Detectin VL and LupoTek Correctin VL

Indication For Use: LupoTek DetecTin VL and CorrecTin VL test kits are qualitative tests intended to aid in the detection of lupus anticoagulants (LA) in citrated human plasma by the dilute Russell's viper venom method in professional clinical laboratories.

Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Leake L. K

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K083878

Regulation Number and Section

§ 864.8950 Russell viper venom reagent.

(a)
Identification. Russell viper venom reagent is a device used to determine the cause of an increase in the prothrombin time.(b)
Classification. Class I (general controls).