PHOSPHOPLASTIN RL

K040296 · R2 Diagnostics, Inc. · GJS · May 24, 2004 · Hematology

Device Facts

• Record ID: K040296
• Device Name: PHOSPHOPLASTIN RL
• Applicant: R2 Diagnostics, Inc.
• Product Code: GJS · Hematology
• Decision Date: May 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7750
• Device Class: Class 2

Intended Use

The Phosphoplastin RL Prothrombin Time reagent is a liquid PT reagent containing thromboplastin derived from rabbit brain and calcium ions for use in the determination of Prothrombin Time (PT) and related coagulation procedures. The PT test is a one-stage PT test used in routine patient screening for disorders in the extrinsic pathway of coagulation and to monitor patients undergoing Oral Anti-Coagulant (OAC) therapy. Phosphoplastin RL should only be used in an appropriate clinical laboratory by qualified laboratory personnel and is provided ready-to-use.

Device Story

Phosphoplastin RL is a liquid, ready-to-use reagent containing rabbit brain-derived thromboplastin, calcium ions, buffers, stabilizers, and preservatives. Used in clinical laboratories by qualified personnel to perform one-stage prothrombin time (PT) tests on citrated human plasma. The reagent reacts with plasma samples to detect deficiencies in coagulation factors II, V, VII, and X. Results are used by clinicians to screen for extrinsic pathway disorders and manage oral anticoagulant therapy. The device provides quantitative assay results, aiding in clinical decision-making regarding patient coagulation status.

Clinical Evidence

Bench testing only. Precision/reproducibility evaluated on ACL 3000+ and STA Compact analyzers; within-run CV 0.1–2.9%, between-run CV 0.54–1.31%. Method comparison (N=105) against predicate showed high correlation (R² 0.92–0.98 for seconds and INR). Interference studies (bilirubin, hemoglobin, lipids) showed no significant difference from predicate. Reference range established using 120 normal donors.

Technological Characteristics

Liquid, ready-to-use reagent. Composition: rabbit brain-derived thromboplastin, calcium ions, buffers, stabilizers, preservatives. Principle: one-stage prothrombin time (PT) assay. Compatible with photo-optical and mechanical coagulation analyzers.

Indications for Use

Indicated for general patient population requiring routine screening for extrinsic coagulation pathway deficiencies or monitoring of oral anticoagulant therapy.

Regulatory Classification

Identification

A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).

Predicate Devices

• R2 Diagnostics Phosphoplastin R (K940082)

Submission Summary (Full Text)

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| 8.0 Premarket Notification 510(k) Summary<br>[As required by section 807.92(c)] | |
|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Michael J. Morris<br>R2 Diagnostics, Inc.<br>412 South Lafayette Blvd.<br>South Bend, IN 46601<br>USA |
| Contact: | Dr. Peggy S. Carter<br>R2 Diagnostics, Inc.<br>412 South Lafayette Blvd.<br>South Bend, IN 46601<br>TEL: [phone]<br>FAX: [phone] |
| Date: | December 19, 2003 |
| Trade Name: | R2 Diagnostics Phosphoplastin RI |
| Common Name: | Prothrombin Time |
| Classification Name: | Test, Time, Prothrombin<br>(per 21 CFR section 864.7750) |
| Comparison Device: | Phosphoplastin R, K940082 |

# Description of the Device and Intended Use

Phosphoplastin RL PT reagent is a liquid, ready-to-use reagent containing thromboplastin derived from rabbit brain, calcium ions, buffers, stabilizers and preservatives. Phosphoplastin RL is intended for use in a one-stage prothrombin time (PT) test on citrated human plasma. The PT test is a quantitative assay used in the general patient population for routine screening to detect deficiencies in the extrinsic pathway of coagulation. The PT test is also used to monitor oral anticoagulant therapy and should be used in a clinical laboratory by qualified laboratory personnel.

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### Summary of Substantial Equivalence Comparisons

R2 Diagnostics Phosphoplastin RL is substantially equivalent in intended use and performance to Phosphoplastin R. Both the predicate device and the proposed product are formulated to detect deficiencies in factors II, V, VII, and X (PT and PT-based factor assays). Both reagents are also sensitive to oral anticoagulants. In correlation studies normal and abnormal patient plasma, as well as plasma samples from patients undergoing oral anticoagulant therapy, were tested using both reagents. Comparison of INR data from PT testing at two sites and on two different instrument types yielded correlation coefficients of r2 = 0.986 (photo-optical), slope = 0.882 and r2 = 0.915 (mechanical), slope = 1.162. Within-run and between-run precision studies were also performed and CV's of less than 3% were obtained for the proposed device. CV's of less than 3% are also reported for the predicate device in the manufacturers directional insert.

## Conclusion: Substantial Equivalence Statement

In Summary, the identical intended use, similar technological characteristics and the performance data provided in this premarket notification demonstrate that R2 Phosphoplastin RL is substantially equivalent to Phosphoplastin R.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Peggy Carter, Ph.D. Director, Product Development R2 Diagnostics 412 S. Lafayette Boulevard South Bend, Indiana 46601

MAY 2 4 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Re: k040296

Trade/Device Name: Phosphoplastin RL Regulation Number: 21 CFR § 864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: II Product Code: GJS Dated: May 4, 2004 Received: May 5, 2004

Dear Dr. Carter:

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); and good manufacturing practice 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 Scction 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.

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If you desire specific information about the application of labeling requirements to your device, or guestions on the promotion and advertising of your device, 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" (21CFR Part 807.97). 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/dsma/dsmamain.html.

Sincerely yours,

Joseph L. Arblett

Joseph L. Hackett, Ph.D. Acting 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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### 6.0 Indications for Use

510(k) Number (if known)K040296

Phosphoplastin RL Device Name:

Indications for Use:

#### Statement of Indications for Use

The Phosphoplastin RL Prothrombin Time reagent is a liquid PT reagent containing 1 no 1 hoophopiastin derived from rabbit brain and calcium ions for use in the determination of Prothrombin Time (PT) and related coagulation procedures. The PT test is a one-stage I roubomom This (1 ) (1 ) (1 ) (1 ) ) ) (1 ) ) = (1 ) = ) = (1 ) = ) = (1 ) = (1 ) = ) = (1 ) test is used in routine patient screening for disorders in the extrinsic pathway of test is used in round panel patients undergoing Oral Anti-Coagulant (OAC) therapy. Phosphoplastin RL should only be used in an appropriate clinical laboratory by qualified laboratory personnel and is provided ready-to-use.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Josephine Runtadi
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) K040296