(160 days)
The Triage Protein C Controls are assayed materials to be used with the Triage Protein C. Test to assist the laboratory in monitoring test performance.
The Triage Protein C Calibration Verification Controls may be used by the laboratory to validate the performance of the Triage Protein C Test throughout the measurable range of the assay.
The Triage Protein C Control 1 and Control 2. and the Triage Protein C Calibration Verification Control Levels A, B and C are single-use, 0.25 mL unit dose liquid external quality control materials prepared with concentrated purified Protein C in human citrated plasma at defined levels. The controls are stored frozen at < -20°C. The liquid external quality control materials are not calibrators and are not used to calibrate the Triage Protein C Test.
Here's a breakdown of the acceptance criteria and the study details for the Triage Protein C Test controls, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The provided text for the Triage Protein C Test controls does not explicitly state numerical acceptance criteria for precision or accuracy. Instead, it uses qualitative descriptors for performance.
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Maintain agreement between observed and expected values for control materials. | "Excellent agreement existed between the observed and expected values." |
| Demonstrate adequate precision. | "No statistically significant differences were observed between sites on test precision." |
| Validate performance throughout the measurable range of the assay (for calibration verification controls). | Addressed by the overall performance testing, implying suitability for this purpose. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 240 coded samples.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "three different sites," which suggests a multi-center study, but it doesn’t specify if these were in the US or other countries. The study appears to be prospective as it describes the evaluation of the controls.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For quality control materials, the "ground truth" (expected values) is typically established through a rigorous process of assaying the control material using a reference method or multiple validated methods, often involving independent laboratories or highly calibrated instruments. The document refers to "expected values" but doesn't detail how these were established or if experts were involved in setting them.
4. Adjudication Method for the Test Set
This information is not provided in the document. Adjudication methods are typically relevant for studies where a "true" diagnosis or classification needs to be resolved among multiple interpretations (e.g., by different readers). For a study evaluating controls against "expected values," a formal adjudication method as described (e.g., 2+1, 3+1) is less applicable. The "expected values" themselves serve as the reference.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No, an MRMC comparative effectiveness study was not done. This study is for quality control materials for an instrument, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of "human readers improve with AI vs. without AI assistance" is not relevant to this submission.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No, this is not applicable. The device is a set of control materials used with an assay (the Triage Protein C Test), not an algorithm or an AI system. The study evaluates the performance of these control materials in monitoring the assay's performance.
7. The Type of Ground Truth Used
- The ground truth used was based on "expected values" for protein C concentrations in the control materials. How these "expected values" were precisely determined (e.g., against a reference standard, by a consensus of multiple validated assays, or pathology results) is not explicitly detailed beyond the mention of prepared materials 'at defined levels'. It's implied that these 'defined levels' are the reference.
8. The Sample Size for the Training Set
- This information is not applicable as the device is a control material, not an algorithm or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable for the same reason as in point 8.
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510(k) Summary of Safety and Effectiveness B.
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.
K062840 The assigned 510(k) number is: __
Name and Address of Submitter 1.
Company Name: Address:
Totephone: Telefax:
Contact Person:
Biosite Incorporated 9975 Summers Ridge Road San Diego, CA 92121 (858) 805-2722 (858) 586-7543
Fil V. Buenviaje Manager, Regulatory Compliance
Date Summary Prepared:
February 13, 2007
Controls
2. Device Name and Classification
Trade Name:
Common Name:
Triage® Protein C Controls and Triage® Protein C Calibration Verification
Protein C Controls; Single (Specified) Analyte Controls (Assayed and Unassayed)
Classification of Device:
21 CFR 862.1660, Quality Control Material (Assayed and Unassayed) Product Code: JJX
3. Predicate Devices
ter the state of the state of the states of the
Triage® BNP (B-Type Natriuretic Peptide) Controls (K000230) PrognostiX CardioMPO™ Control Kit (K050029)
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4. Device Description
The Triage Protein C Control 1 and Control 2. and the Triage Protein C Calibration Verification Control Levels A, B and C are single-use, 0.25 mL unit dose liquid external quality control materials prepared with concentrated purified Protein C in human citrated plasma at defined levels. The controls are stored frozen at < -20°C. The liquid external quality control materials are not calibrators and are not used to calibrate the Triage Protein C Test.
5. Intended Use
The Triage Protein C Controls are assayed materials to be used with the Triage Protein C Test to assist the laboratory in monitoring test performance.
The Triage Protein C Calibration Verification Controls may be used to validate the performance of the Triage Protein C Test throughout the measurable range of the assay.
6. Product Performance
The performance of the Controls were evaluated using a panel consisting of 240 coded samples. Testing was conducted in duplicate, twice per day over twenty working days at three different sites. Excellent agreement existed between the observed and expected values. No statistically significant differences were observed between sites on test precision.
7. Comparison to Predicate Device
The Triage Protein C Controls and Triage Protein C Calibration Verification Controls employ similar characteristics to predicate devices including single analyte assay control, 2 or 3 levels, liquid control, human plasma/serum matrix and ≤ -20℃ storage condition.
8. Conclusion
The information presented in this Premarket Notification demonstrates the suitability of the device 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. Further, the information presented herein indicate that the Triage Protein C Controls and Triage Protein C Calibration Verification Controls are substantially equivalent in intended use and performance to other previously cleared control materials, thereby supporting 510(k) clearance.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
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: K062840
MAR 0 1 2007
Trade/Device Name: Triage® Protein C Controls Triage® Protein C Calibration Verification Controls Regulation Number: 21 CFR 864.5425 Multipurpose System For In Vitro Coagulation Studies Regulation Name: Regulatory Class: Class II Product Code: GGN Dated: September 20, 2006 Received: September 22, 2006
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, 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
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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 H. Becker
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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Indications for Use
510(k) Number (if known):
KO62840
Device Name:
Triage® Protein C Controls and Triage® Protein C Calibration Verification Controls
Indications for Use:
The Triage Protein C Controls are assayed materials to be used with the Triage Protein C. Test to assist the laboratory in monitoring test performance.
The Triage Protein C Calibration Verification Controls may be used by the laboratory to validate the performance of the Triage Protein C Test throughout the measurable range of the assay.
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)
Juykins Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety Page 1 of
510(k) K062840
§ 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.