PLASMACON N, PLASMACON L-1, PLASMACON L-2

K062306 · R2 Diagnostics, Inc. · GGC · Mar 16, 2007 · Hematology

Device Facts

• Record ID: K062306
• Device Name: PLASMACON N, PLASMACON L-1, PLASMACON L-2
• Applicant: R2 Diagnostics, Inc.
• Product Code: GGC · Hematology
• Decision Date: Mar 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

PlasmaCon N is a human lyophilized plasma control intended for use as a normal control with citrated plasma to monitor the performance of the Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) tests. PlasmaCon L-1 is a human lyophilized plasma control intended for use as a mid-level abnormal control with citrated plasma to monitor the performance of the Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) tests. PlasmaCon L-2 is a human lyophilized plasma control intended for use as a high level abnormal control with citrated plasma to monitor the performance of the Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) tests.

Device Story

Lyophilized citrated human plasma controls; used to verify system performance for PT and aPTT coagulation assays. Operated by qualified laboratory professionals in clinical settings; used with manual, semi-automated, or automated coagulation analyzers. Healthcare providers use control results to monitor assay performance and ensure accuracy of patient screening tests. Benefits include standardized quality control for coagulation testing.

Clinical Evidence

Bench testing only. Precision/reproducibility evaluated per CLSI EP15-A guidelines; within-run and between-run CVs <15% across multiple instrument/reagent combinations (ACL3000+, MLA1000c, ACL Advance, Dade BCS, Stago STA). Stability validated via real-time open/closed vial studies.

Technological Characteristics

Lyophilized citrated human plasma. Formulated for use as normal, mid-level abnormal, and high-level abnormal controls. Compatible with manual, semi-automated, and automated coagulation analyzers. No specific hardware or software components; device is a chemical control reagent.

Indications for Use

Indicated for use as quality control material for PT and aPTT coagulation assays in clinical laboratory settings. Intended for use with citrated human plasma samples.

Regulatory Classification

Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• Trinity Biotech Normal Coagulation Control Plasma (K895262)
• Trinity Biotech Abnormal Coagulation Control Plasma Level-1 (K895260)
• Trinity Biotech Abnormal Coagulation Control Plasma Level-2 (K895261)

Submission Summary (Full Text)

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K062306

# 8.0 Premarket Notification 510(k) Summary [As required by section 807.92(c)]

MAR 1 6 2007

| Applicant: | Michael J. Morris<br>R2 Diagnostics, Inc.<br>1801 Commerce Drive<br>South Bend, IN 46628<br>USA |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Marc Goldford |
| | R2 Diagnostics, Inc.<br>1801 Commerce Drive<br>South Bend, IN 46628<br>TEL: [phone]<br>FAX: [phone] |
| Date: | July 24, 2006 |
| Trade Name: | R2 Diagnostics PlasmaCon N,<br>PlasmaCon L-1,<br>PlasmaCon L-2 |
| Common Name: | Controls, Plasma, Normal and Abnormal for<br>Coagulation |
| Classification Name: | Control, Plasma, Normal and Abnormal<br>(per 21 CFR section 864.5425) |
| Comparison Device: | Normal Coagulation Control Plasma<br>K895262<br>Abnormal Coagulation Control Plasma<br>Level-1 K895260<br>Abnormal Coagulation Control Plasma<br>Level-2 K895261 |

Description of the Device

The PlasmaCon Control Plasma devices contain lyophilized citrated human plasma, for use in the verification of system performance for PT and aPTT assays. The Plasma Ton be control plasmas should only be used in an appropriate clinical laboratory by qualified laboratory professionals. The tests may be performed manually, or using semi-automated and automated coagulation analyzers.

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## Statement of the Intended Use

PlasmaCon N is a human lyophilized plasma control intended for use as a normal control with citrated plasma to monitor the performance of the Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) tests.

PlasmaCon L-1 is a human lyophilized plasma control intended for use as a mid-level abnormal control with citrated plasma to monitor the performance of the Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) tests.

PlasmaCon L-2 is a human lyophilized plasma control intended for use as a high level abnormal control with citrated plasma to monitor the performance of the Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) tests.

### Summary of Substantial Equivalence Comparisons

R2 Diagnostics' PlasmaCon Control Plasmas are substantially equivalent in intended use and performance to Normal and Abnormal Control Plasma devices currently marketed by Trinity Biotech. Both the predicate device and the proposed product for in vitro diagnostic use in routine patient screening tests. Both are formulated from citrated human plasma.

Precision studies were performed to establish Within Run and Between Run CVs according to the following procedure developed under NCCLS EP-15A: User Demonstration of Performance for Precision and Accuracy; Approved Guidelines. For within run, 10 vials of each sample were pooled, tested, and recorded in duplicate or triplicate. For between run, 2 vials of each sample were pooled, tested in duplicate, and recorded each day for 5 days.

In comparison studies normal and abnormal control plasma controls were tested using PT and aPTT reagents from multiple manufacturers on multiple instrument types to include:

- r2 Diagnostics Phospholin ES on the ACL3000+, MLA1000c and ACL Advance. .
- r2 Diagnostics Phosphoplastin RL on the ACL3000+, MLA1000c and ACL . Advance.
- . Dade-Behring Thromborel S on the Dade BCS.
- . Dade-Bchring Pathromtin SL on the Dade BCS.
- Stago Neoplastine CI+ on the Stago STA. .
- Stago Auto PTT on the Stago STA. .

Within-run and between-run precision studies were performed and CV's of less than 15% were obtained for the proposed device. CV's of less than 15% are reported for the predicate device in this study.

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## Conclusion: Substantial Equivalence Statement

In Summary, the similar intended use, technological characteristics and the performance data provided in this premarket notification demonstrate that R2 PlasmaCon N, PlasmaCon L-1, and PlasmaCon L-2 are substantially equivalent to (Trinity Biotech) Medical Diagnostic Technologies, Normal Coagulation Control Plasma, Abnormal Coagulation Control Plasma 1, and Abnormal Coagulation Control Plasma 2.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

R2 DIAGNOSTICS, INC. C/O Kara M. Young 1801 Commerce Drive South Bend, Indiana 46628

MAR 1 6 2007

Re: k062306

Trade/Device Name: PlasmaCon N, PlasmaCon L-1, PlasmaCon L-2 Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose System For In Vitro Coagulation Studies Regulatory Class: Class II Product Code: GIZ, GGC Dated: July 24, 2006 Received: August 8, 2006

Dear Ms. Young:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050, 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.

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Page 2 –

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance 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/industry/support/index.html.

Sincerely yours.

Robert Beckerf

Robert L. Becker, Jr., MD PhD Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Premarket Notification 510(k) PlasmaConN, PlasmaCon L-1, PlasmaCon L-2

#### 6.0 Indications for Use

510(k) Number (if known): K 06 2 306

Device Name: ___PlasmaCon N_

Indications for Use:

#### Statement of Indications for Use

PlasmaCon N is a human lyophilized plasma control intended for use as a normal control with citrated plasma to monitor the performance of the prothrombin time (PT) and activated partial thromboplastin time (aPTT) tests.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Josephine Buistida
Division Sign-Off

Page 1 of 1

Office of In Vitro Diagnostic Device Evaluation and Safety

(Posted November 13, 2003) 510(K) K062306

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510(k) Number (if known): K_06230 6

Device Name: __ PlasmaCon L-1_

Indications for Use:

#### Statement of Indications for Use

PlasmaCon L-1 is a human lyophilized plasma control intended for use as a mid-level abnormal control with citrated plasma to monitor the performance of the prothrombin time (PT) and activated partial thromboplastin time (aPTT) tests.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Juchere Burtuta
Division Sign-Off

Page 1 of 1

Office of In Vitro Diagnostic Device Evaluation and Safety

(Posted November 13, 2003)(K) K062306

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### (10(k) ווני remarket Notification PlasmaConN, PlasmaCon L-1, PlasmaCon L-2

510(k) Number (if known): K_062306

Device Name: _ PlasmaCon L-2_

Indications for Use:

#### Statement of Indications for Use

PlasmaCon L-2 is a human lyophilized plasma control intended for use as a high level abnormal control with citrated plasma to monitor the performance of the prothrombin time (PT) and activated partial thromboplastin time (aPTT) tests.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Josephine Bautista

Page 1 of 1

Office of In Vitro Diagnostic Device Evaluation and Safety

(Posted November 13, 2003) K 06 2306