LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA

K083878 · R2 Diagnostics, Inc. · GIR · Jun 25, 2010 · Hematology

Device Facts

• Record ID: K083878
• Device Name: LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA
• Applicant: R2 Diagnostics, Inc.
• Product Code: GIR · Hematology
• Decision Date: Jun 25, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8950
• Device Class: Class 1

Intended 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. 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 Story

LupoTek Detectin VL and Correctin VL are in vitro diagnostic reagents for lupus anticoagulant (LA) detection in citrated human plasma. Unlike traditional Russell's viper venom, these use Vipera lebetina venom to activate Factor X, which, with Factors V, II, calcium, and phospholipid, generates thrombin to clot fibrinogen. Detectin VL (low phospholipid) screens for prolonged clotting times; Correctin VL (high phospholipid) neutralizes LA to normalize clotting times, confirming presence. PlasmaCon LA is a lyophilized, LA-positive abnormal control plasma used to monitor assay performance. Used in clinical laboratories by technicians/pathologists; results aid clinicians in diagnosing LA-related conditions. Benefits include standardized, reliable LA screening and quality control.

Clinical Evidence

Bench testing only. Precision studies (CLSI EP5-A2) on three lots showed within-device CV < 5%. Method comparison study on 155 patient samples across three sites compared to predicate reagents yielded 98% PPA (91.9-99.4% CI) and 96% NPA (88.0-98.5% CI). Interference testing established limits for hemolysis, icterus, lipemia, and heparin. No clinical prospective/retrospective studies were required.

Technological Characteristics

Lyophilized reagents containing Vipera lebetina venom, phospholipids, anti-heparin agents, calcium, buffers, stabilizers, and dye. Sensing principle: dilute venom clotting assay (dRVVT). Connectivity: standalone reagent for use on automated coagulation analyzers (e.g., STA Compact). Sterilization: not applicable (reagents).

Indications for Use

Indicated for use in professional clinical laboratories to aid in the detection of lupus anticoagulants in citrated human plasma samples and as an abnormal quality control plasma for monitoring diagnostic assay performance.

Regulatory Classification

Identification

Russell viper venom reagent is a device used to determine the cause of an increase in the prothrombin time.

Predicate Devices

• STA®-Staclot® DRVV Screen and STA®-Staclot® DRVV Confirm (k061805)
• American Diagnostica LAtrol Abnormal Control (k935254)

Submission Summary (Full Text)

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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: | [e-mail] |
| Date of Preparation: | 23 Jun 2010 |

#### 2) Device Name(s)

| Trade Name: | LupoTek Detectin VL<br>LupoTek 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)

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.

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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

### 5) Intended Use(s)

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.

## 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 and<br>CorrecTin VL test kits are<br>qualitative tests intended to aid<br>in the detection of lupus<br>anticoagulants (LA) in citrated<br>human plasma by the dilute<br>Russell's viper venom method<br>in professional clinical<br>laboratories. | The STA Staclot dRVV Screen<br>and STA Staclot dRVV Confirm<br>kits are intended for the<br>detection of the lupus<br>anticoagulants(LA) in plasma<br>by the dilute Russell's viper<br>venom test (1) performed with<br>analyzers of the STA line<br>suitable to these reagents. |
| Patient sample | Citrated human plasma | Citrated human plasma |
| Measurement<br>principle | Vipera lebetina venom, like<br>Russell's viper venom, will<br>directly activate Factor X<br>without requiring Factor VII.<br>The activated Factor X in<br>conjunction with Factors V, II,<br>calcium ions and phospholipid<br>will generate thrombin which<br>converts fibrinogen to fibrin,<br>producing a clot in the test<br>system.<br>The LupoTek DetecTin VL is<br>designed as the screening<br>reagent to detect a prolongation<br>of the clotting time. The<br>LupoTek CorrecTin VL is a<br>high phospholipid reagent that<br>neutralizes the LA and corrects<br>the clotting time to normal,<br>confirming the presence of a<br>Lupus Anticoagulant. | Lupus anticoagulants are<br>antibodies directed against<br>phospholipid/protein complexes.<br>Staclot® dRVV Screen test is<br>performed with a low<br>phospholipids concentration<br>reagent to screen samples. If<br>lupus anticoagulants are present,<br>the clotting time will<br>be prolonged.<br>The Staclot® dRVV Confirm<br>Reagent contains a higher<br>phospholipids concentration<br>to neutralize the LA present in<br>the plasma to be tested. The<br>clotting time obtained<br>with the Staclot® dRVV<br>Confirm Reagent will be shorter<br>than the one observed with<br>the Staclot® dRVV Screen<br>reagent. |
| Format | Lyophilized reagents consisting<br>of venom, phospholipid,<br>anti-heparin agent, calcium,<br>buffers, stabilizers, and a dye. | Lyophilized reagents consisting<br>of venom, phospholipid,<br>anti-heparin agent, calcium,<br>buffers, and stabilizers. |
| Analyte | Lupus anticoagulants | Lupus anticoagulants |
| | Differences | |
| Item | Submitted Device | Predicate Device |
| Venom source | Vipera lebetina | Vipera russelli |
| Color | Detectin VL: Blue<br>Correctin VL: Pink | Screen: Green<br>Confirm: Light Orange |
| Reconstituted<br>Stability | 2-8C: 24 hr<br>RT: 8 hr | 2-8C: not listed<br>RT: not listed |

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| Table 2: Comparison of submitted device PlasmaCon LA to<br>predicate 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 hr<br>RT: 4 hr | 2-8C: 8 hr<br>(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 [phone]. 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 [phone] or [phone] 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