(543 days)
Not Found
No
The summary describes a qualitative in vitro diagnostic test kit and a quality control plasma, both based on chemical reactions and clotting time measurements. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is used for diagnostic testing (detecting lupus anticoagulants) and quality control in clinical laboratories, not for treating a condition or disease.
Yes
The "Intended Use / Indications for Use" states that the test kits are "qualitative tests intended to aid in the detection of lupus anticoagulants (LA)". Additionally, "PlasmaCon LA is intended for use as an LA positive, abnormal quality control plasma to monitor the performance of diagnostic assays". These phrases clearly indicate the device's role in diagnosis.
No
The device description clearly outlines physical reagents (test kits and control plasma) used in a laboratory setting to perform a diagnostic test. There is no mention of software as the primary or sole component of the device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the test kits are "qualitative tests intended to aid in the detection of lupus anticoagulants (LA) in citrated human plasma... in professional clinical laboratories." This clearly indicates the device is used to examine specimens derived from the human body (plasma) to provide information for diagnostic purposes.
- Device Description: The description details how the reagents interact with components in the plasma to produce a measurable outcome (clotting time) that is indicative of the presence of lupus anticoagulants. This is a typical characteristic of an in vitro diagnostic test.
- Quality Control: The inclusion of PlasmaCon LA, an "LA positive, abnormal quality control plasma," further supports its IVD nature. Quality controls are essential components of in vitro diagnostic testing to ensure the accuracy and reliability of the results.
- Intended User/Care Setting: The intended user is "professional clinical laboratories," which is the typical setting for performing in vitro diagnostic tests.
Based on the provided information, the LupoTek Detectin VL and Correctin VL test kits, along with the PlasmaCon LA control, fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
GIR, GGC
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional clinical laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
percent positive agreement was 98% and the percent negative agreement was 96%.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 VL
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.
1
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 | |
| 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. | The STA Staclot dRVV Screen | |
| and STA Staclot dRVV Confirm | ||
| kits are intended for the | ||
| detection of the lupus | ||
| anticoagulants(LA) in plasma | ||
| by the dilute Russell's viper | ||
| venom test (1) performed with | ||
| analyzers of the STA line | ||
| suitable to these reagents. | ||
| Patient sample | Citrated human plasma | Citrated human plasma |
| Measurement | ||
| principle | 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. | ||
| The LupoTek DetecTin VL is | ||
| designed as the screening | ||
| reagent to detect a prolongation | ||
| of the clotting time. The | ||
| LupoTek CorrecTin VL is a | ||
| high phospholipid reagent that | ||
| neutralizes the LA and corrects | ||
| the clotting time to normal, | ||
| confirming the presence of a | ||
| Lupus Anticoagulant. | Lupus anticoagulants are | |
| antibodies directed against | ||
| phospholipid/protein complexes. | ||
| Staclot® dRVV Screen test is | ||
| performed with a low | ||
| phospholipids concentration | ||
| reagent to screen samples. If | ||
| lupus anticoagulants are present, | ||
| the clotting time will | ||
| be prolonged. | ||
| The Staclot® dRVV Confirm | ||
| Reagent contains a higher | ||
| phospholipids concentration | ||
| to neutralize the LA present in | ||
| the plasma to be tested. The | ||
| clotting time obtained | ||
| with the Staclot® dRVV | ||
| Confirm Reagent will be shorter | ||
| than the one observed with | ||
| the Staclot® dRVV Screen | ||
| reagent. | ||
| Format | Lyophilized reagents consisting | |
| of venom, phospholipid, | ||
| anti-heparin agent, calcium, | ||
| buffers, stabilizers, and a dye. | Lyophilized reagents consisting | |
| of 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: Blue | |
| Correctin VL: Pink | Screen: Green | |
| Confirm: Light Orange | ||
| Reconstituted | ||
| Stability | 2-8C: 24 hr | |
| RT: 8 hr | 2-8C: not listed | |
| RT: not listed |
3
| Table 2: Comparison of submitted device PlasmaCon LA to
| 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 | |
| RT: 4 hr | 2-8C: 8 hr | |
| (RT: not listed) |
·
4
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
5
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
6
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
7
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