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 Description

The PlasmaCon Control Plasma devices contain lyophilized citrated human plasma, for use in the verification of system performance for PT and aPTT assays.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the PlasmaCon N, PlasmaCon L-1, and PlasmaCon L-2 devices, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Within-run %CV < 15%	Obtained for the proposed device
Between-run %CV < 15%	Obtained for the proposed device

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

Sample Size:
- Within-run: 10 vials of each sample (PlasmaCon N, PlasmaCon L-1, PlasmaCon L-2) were pooled, tested in duplicate or triplicate.
- Between-run: 2 vials of each sample were pooled, tested in duplicate, and recorded daily for 5 days.
Data Provenance: The text does not specify the country of origin for the data. The study was a prospective precision study, as it was performed to establish CVs for the new R2 Diagnostics PlasmaCon devices.

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

This type of information is not applicable (N/A) to this device and study. The PlasmaCon devices are control plasmas used to monitor the performance of PT and aPTT assays, not to diagnose conditions directly. Therefore, there is no "ground truth" in the sense of a medical diagnosis established by experts. The study focuses on the precision of the controls themselves when used in laboratory settings.

4. Adjudication Method for the Test Set

This is N/A for similar reasons as point 3. There was no expert adjudication involved, as the study's goal was to measure the statistical precision (CVs) of the control plasmas.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study investigates how human readers' performance changes with or without AI assistance, which is not relevant for a control plasma device. The study focused on the performance of the control plasmas compared to a predicate device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is N/A as the device is a control plasma, not an algorithm or AI system. The study evaluated the performance of the physical control plasma in laboratory settings, which can be performed manually, semi-automated, or fully automated, but the evaluation is of the control itself, not an algorithm's standalone performance.

7. The Type of Ground Truth Used

This is N/A as the study did not involve establishing a direct "ground truth" for a medical condition. Instead, the study aimed to demonstrate the precision and substantial equivalence of the control plasmas to predicate devices, using established laboratory protocols (NCCLS EP-15A) to measure Within-Run and Between-Run Coefficient of Variation (CV). The "truth" in this context refers to the expected performance characteristics of a high-quality control plasma.

8. The Sample Size for the Training Set

This information is N/A. The document describes a study to evaluate the performance of a medical device (control plasma), not the development or training of an algorithm or AI model. Therefore, there is no "training set" in this context.

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

This information is N/A as there was no training set for an algorithm.

Summary

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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. MorrisR2 Diagnostics, Inc.1801 Commerce DriveSouth Bend, IN 46628USA
Contact:	Marc Goldford
	R2 Diagnostics, Inc.1801 Commerce DriveSouth Bend, IN 46628TEL: (574) 288-4377FAX: (574) 288-2272
Date:	July 24, 2006
Trade Name:	R2 Diagnostics PlasmaCon N,PlasmaCon L-1,PlasmaCon L-2
Common Name:	Controls, Plasma, Normal and Abnormal forCoagulation
Classification Name:	Control, Plasma, Normal and Abnormal(per 21 CFR section 864.5425)
Comparison Device:	Normal Coagulation Control PlasmaK895262Abnormal Coagulation Control PlasmaLevel-1 K895260Abnormal Coagulation Control PlasmaLevel-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

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 (240) 276-0450. 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 (800) 638-2041 or (240) 276-3150 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

Regulation Number and Section

§ 864.5425 Multipurpose system for in vitro coagulation studies.

(a)
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.(b)
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.