The Phospholin ES Activated Partial Thromboplastin Time reagent is a liquid activated reagent with phospholipids derived from soybean lecithin for use in the determination of Activated Partial Thromboplastin Time (APTT) and related coagulation procedures. Phospholin ES is to be used as an APTT reagent (qualitative assay) on patient plasma for the routine screening in the general patient population for deficiencies involving the intrinsic pathway of coagulation. Phospholin ES is sensitive to lupus-like inhibitors.

Device Description

R2 Diagnostics Phospholin ES is a liquid reagent containing ellagic acid as the activator and phospholipids derived from soybean lecithin. The reagent also contains buffer and preservatives. Phospholin ES is an in vitro diagnostic reagent intended for use for the performance of the activated partial thromboplastin time two-stage test (APTT) and related coagulation factor assays. Phospholin ES is sensitive to lupus anticoagulants. Phospholin ES as with any APTT test requires the addition on 0.02-0.025M Calcium Chloride to perform the assay.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the R2 Diagnostics Phospholin ES device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document frames its "acceptance criteria" and "device performance" in terms of substantial equivalence to a predicate device. The performance criteria are primarily correlation coefficients and precision for various sample types.

Acceptance Criterion (Type)	Predicate Device Performance	Proposed Device Performance (Reported)
Correlation: Normal & Abnormal Patients (Photo-optical)	N/A (implied by predicate's established performance)	R = 0.92, Slope = 0.864
Correlation: Normal & Abnormal Patients (Mechanical)	N/A	R = 0.93, Slope = 1.09
Correlation: Lupus Anticoagulant Samples (Photo-optical)	N/A	R = 0.94, Slope = 0.866
Correlation: Lupus Anticoagulant Samples (Mechanical)	N/A	R = 0.99, Slope = 0.627
Precision: Within-run CV	< 3% (Reported in manufacturer's directional insert)	< 3%
Precision: Between-run CV	< 3% (Reported in manufacturer's directional insert)	< 3%

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

Sample Size: The document does not explicitly state the exact number of samples used in the correlation studies. It mentions "normal and abnormal patients, as well as samples from patients positive for lupus anticoagulants."
Data Provenance: Not specified, but likely retrospective convenience sampling given the nature of the study as a comparison to an existing predicate device. The country of origin is not mentioned.

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

This information is not provided. For an in vitro diagnostic device like Phospholin ES, the "ground truth" for the test set would typically be the results obtained from the predicate device itself, which is already an accepted diagnostic method. The document relies on a comparison between the new device and the predicate device, rather than an independent "expert ground truth" as might be seen in imaging or pathology studies.

4. Adjudication Method for the Test Set

Not applicable. The study is a direct comparison of results between two in vitro diagnostic reagents rather than human interpretation with potential for disagreement requiring adjudication.

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

No. This is an in vitro diagnostic reagent study, not an imaging or interpretation study involving multiple human readers.

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

Yes, this is an in vitro diagnostic reagent. Its performance is evaluated on its own, producing a quantitative result (APTT time) from a biological sample. Human interpretation is subsequent to the reagent's performance in the laboratory instrument.

7. The Type of Ground Truth Used

The "ground truth" in this context is the performance of the predicate device (Dade Actin FSL and Stago Calcium Chloride). The study aimed to show that Phospholin ES's results correlate highly with and are interchangeable with those obtained from the predicate device.

8. The Sample Size for the Training Set

Not applicable. This type of in vitro diagnostic reagent development does not typically involve a "training set" in the machine learning sense. The formulation of the reagent is based on chemical and biological principles, and its performance is validated against established methods.

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

Not applicable. As noted above, there isn't a "training set" in the conventional sense for this type of device.

Summary

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Premarket Notification 510(k)KO3347 / Phospholin ES

FEB -- 4 2004

8.0 Premarket Notification 510(k) Summary

[As required by section 807.92(c)]

Applicant:	Michael J. MorrisR2 Diagnostics, Inc.412 South Lafayette Blvd.South Bend, IN 46601USA
Contact:	Dr. Peggy S. CarterR2 Diagnostics, Inc.412 South Lafayette Blvd.South Bend, IN 46601TEL: (574) 288-4377FAX: (574) 288-2272
Date:	October 22, 2003
Trade Name:	R2 Diagnostics Phospholin ES
Common Name:	Activated Partial Thromboplastin Time
Classification Name:	Test, Time, Partial Thromboplastin(per 21 CFR section 864.7925)
Comparison Device:	Dade Actin FSL, K863594Stago Calcium Chloride

Description of the Device and Intended Use

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Summary of Substantial Equivalence Comparisons

R2 Diagnostics Phospholin ES and Calcium Chloride are substantially equivalent in intended use and performance to Dade Actin FSL and Stago Calcium Chloride. Both the predicate device and the proposed product are formulated to detect deficiencies in factors II, V, VIII, IX, XI, and XII (APTT and APTT-based factor assays). Both reagents are also sensitive to lupus anticoagulants. In correlation studies, APTT testing of normal and abnormal patients, as well as samples from patients positive for lupus anticoagulants were tested using both reagents. APTT testing at two sites and on two different instrument types vielded correlation coefficients of R = 0.92 (photo-optical), slope = 0.864 and R = 0.93 (mechanical), slope = 1.09. In addition correlation coefficients of R = 0.94 (photo-optical), slope = 0.866 and R = 0.99 (mechanical), slope = 0.627 were obtained for lupus anticoagulant positive samples. 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. The Calcium Chloride products are identical in formulation of 0.025M Calcium Chloride.

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 Phospholin ES and Calcium Chloride are substantially equivalent to Dade Actin FSL and Stago Calcium Chloride.

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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 features a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

FEB - 4 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K033471

Trade/Device Name: Phospholin ES and Calcium Chloride Regulation Number: 21 CFR § 864.7925 Regulation Name: Partial Thromboplastin Time Tests Regulatory Class: II Product Code: GGW Dated: January 8, 2004 Received: January 14, 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 dcvices 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 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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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Joseph L. Archellett

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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Indications for Use

510(k) Number (if known): _K033471

Device Name: Phospholin ES and Calcium Chloride

Indications for 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 Kantzler

Division Sien-Of

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k03347/

(Posted November 13, 2003)

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Regulation Number and Section

§ 864.7925 Partial thromboplastin time tests.

(a)
Identification. A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.(b)
Classification. Class II (performance standards).