(153 days)
The Triage® Protein C Test is a rapid, point-of-care fluorescence immunoassay to be used with the Triage Meters for the rapid, quantitative determination of Protein C in citrated whole blood or plasma specimens in patients with signs and symptoms of sepsis. The test is not intended for use in patients with vitamin K deficiency, DIC, cancers, HIV and liver and renal diseases as these disease conditions have not been evaluated.
The Triage Protein C Test is a single-use device containing murine monoclonal antibodies against Protein C labeled with a fluorescent dye and purified Protein C antigen immobilized on the solid phase, and stabilizers. Additionally, there are built-in control features that ensure that the test was performed properly and the reagents were functionally active. The Test Cartridge is inserted into the Triage Meter and results are measured and displayed on the display screen or printout in approximately 15 minutes. Internal assay controls (positive and negative controls) and automatic endpoint detection technology is used to indicate assay completion.
The provided text describes a 510(k) summary for the Triage® Protein C Test, a rapid, point-of-care fluorescence immunoassay. However, it does not contain specific acceptance criteria (performance targets for sensitivity, specificity, accuracy, etc.) or a detailed study report that proves the device meets those criteria.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Asserachrom® Protein C Kit) through a method comparison study. It establishes that the new device yields similar results to the predicate.
Given the information, I can extract and infer the following:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., "The device must achieve >90% sensitivity"). Instead, the fundamental "acceptance criteria" for this 510(k) submission is demonstrating substantial equivalence to the predicate device.
| Acceptance Criteria (Inferred from 510(k) process) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Two hundred twenty-five split patient samples run with Triage Protein C Test and predicate method yielded similar results. |
| Compliance with NCCLS EP9-A2 | Testing conducted in accordance with NCCLS Evaluation Protocol EP9-A2. |
| Performance across reportable range | Equivalence demonstrated using patient and quality control samples with measured Protein C values spanning the reportable range. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: 225 split patient samples.
- Data Provenance: The samples were collected from patients who presented with suspected or proven infection, evidence of systemic inflammation, and at least one sepsis-induced organ failure. This suggests a prospective collection within specific clinical settings (sepsis patients). The study was conducted at three independent clinical laboratory sites, but their geographical location (country of origin) is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The "ground truth" in this context is implicitly the measurement from the predicate device. Experts would typically be involved in interpreting patient conditions or establishing true disease states for diagnostic accuracy studies, which is not the primary focus here (it's a method comparison).
4. Adjudication Method for the Test Set:
This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are usually relevant when establishing a "ground truth" through expert consensus, especially when there's disagreement among reviewers of images or clinical data. In this method comparison study, the "truth" for comparison is the result from the predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done? No, a MRMC comparative effectiveness study was not done. This study is a method comparison between the new device and a predicate device, focusing on quantitative agreement. It does not involve human readers interpreting results with and without AI assistance to assess improved effectiveness.
- Effect size of human readers improvement with AI vs without AI assistance: Not applicable, as no such study was performed.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop):
- Was it done? Yes, this study effectively represents a standalone performance. The Triage Protein C Test is a fully automated immunoassay read by the Triage Meter. Its performance, as compared to the predicate device, is the standalone performance of the device and its associated meter. The study compared the quantitative output of the Triage Protein C Test directly against the predicate method on patient samples.
7. Type of Ground Truth Used:
- The "ground truth" for this method comparison study was the results obtained from the predicate device, Asserachrom® Protein C Kit (K854016). The study aimed to show that the Triage Protein C Test's measurements align with those of the legally marketed predicate device.
8. Sample Size for the Training Set:
This information is not provided. The document describes a study to validate the device's performance, but it does not mention a separate training set. For immunoassay devices, "training" (calibration curve establishment, reagent optimization) is typically part of the manufacturing and development process, rather than a distinct "training set" of patient data as might be seen for machine learning algorithms. The language used ( "manufactured reagents along with patient and quality control samples with measured Protein C values") implies the use of quality control samples which might be analogous to training data but it's not explicitly stated.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided, as details about a distinct "training set" are absent. For the development and calibration of such an immunoassay, the "ground truth" would be established by reference methods or highly characterized calibrators.
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510(k) Summary of Safety and Effectiveness B.
JAN 2 9 2007
Triage® Protein C Test
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
A. Name and Address of Submitter
| Company Name: | Biosite Incorporated |
|---|---|
| Address: | 9975 Summers Ridge RoadSan Diego, CA 92121 |
| Telephone: | (858) 805-2722 |
| Telefax: | (858) 695-7100 |
| Contact Person: | Fil V. BuenviajeManager, Regulatory Compliance |
| Date Summary Prepared: | January 17, 2007 |
Device Name and Classification B.
| Trade Name: | Triage® Protein C Test |
|---|---|
| Common Name: | Protein C |
| Classification of Device: | 21 CFR 864.7290.Factor Deficiency TestProduct Code: GGP |
C. Predicate Device
Asserachrom® Protein C Kit (K854016)
D. Device Description
The Triage Protein C Test is a single-use device containing murine monoclonal antibodies against Protein C labeled with a fluorescent dye and purified Protein C antigen immobilized on the solid phase, and stabilizers. Additionally, there are built-in control features that ensure that the test was performed properly and the reagents were functionally active.
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The Test Cartridge is inserted into the Triage Meter and results are measured and displayed on the display screen or printout in approximately 15 minutes. Internal assay controls (positive and negative controls) and automatic endpoint detection technology is used to indicate assay completion.
ய் Device Intended Use
The Triage Protein C Test is a rapid, point-of-care fluorescence immunoassay to be used with the Triage Meters for the rapid, quantitative determination of Protein C in citrated whole blood or plasma specimens in patients with signs and symptoms of sepsis. The test is not intended for use in patients with vitamin K deficiency, DIC, cancers, HIV and liver and renal diseases as these disease conditions have not been evaluated.
ட் Comparison to Predicate Device
The performance of the Triage Protein C Test was established using samples collected from patients who presented with suspected or proven infection, evidence of systemic inflammation and at least one sepsis-induced organ failure who were enrolled in a previous clinical investigation. Two hundred twenty-five split patient samples were run in the Triage Protein C Test and a predicate method for the purpose of determining if the two methods yield similar results. Testing was conducted at three independent clinical laboratory sites in accordance with NCCLS Evaluation Protocol EP9-A2, Vol. 22, No. 19, Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second Edition.
G. Conclusion
The information presented in this Premarket Notification demonstrates that the performance of the Triage Protein C Test for use with citrated human blood and plasma is substantially equivalent to the predicate device.
Equivalence was demonstrated using manufactured reagents along with patient and quality control samples with measured Protein C values spanning the reportable range of the assay.
These studies demonstrate the substantial equivalence of the Triage Protein C Test to existing products already marketed for the quantitative determination of Protein C. They further demonstrated the suitability of the product for laboratory and professional use. Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution.
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Image /page/2/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol in the center. The symbol resembles a stylized eagle or bird in flight, composed of curved lines. The overall design is simple and monochromatic.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
BIOSITE Incorporated C/O Fil V. Buenviaje 9975 Summers Ridge Road San Diego, California 92121
Re: K062530
Trade/Device Name: Triage Protein C Test Regulation Number: 21 CFR 864.7290 Regulation Name: Factor Deficiency Test Regulatory Class: Class II Product Code: GGP Dated: August 28, 2006 Received: August 29, 2006
JAN 2 9 2007
Dear Mr. Buenviaje
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. Drue, 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
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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 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 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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cc: HFZ-401 DMC
the control control control of the control of
and the comments of the comments of the comments of
HFZ-404 510(k) Staff HFZ- 440 Division D.O.
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:
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Indications for Use
510(k) Number (if known):
Device Name:
Triage® Protein C Test
Indications for Use:
The Triage Protein C Test is a rapid, point-of-care fluorescence immunoassay to be used with the Triage Meters for the rapid, quantitative determination of Protein C in citrated whole blood or plasma specimens in patients with signs and symptoms of sepsis. The test is not intended for use in patients with vitamin K deficiency, DIC, cancers, HIV and liver and renal diseases as these disease conditions have not been evaluated.
X ____________________________________________________________________________________________________________________________________________________________________________ Prescription Use (Per 21 CFR 801.109)
Over-The Counter Use (Per 21 CFR 807 Subpart C)
(Please Do Not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Suphine Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety Page 1 of
510(k) K062530
§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).