(127 days)
In vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative immunological determination of human complement C4 in serum and plasma. Aid in detecting the presence and level of C4 found in autoimmune diseases, infections and inflammatory disorders.
The Tina-quant Complement C4 Test System is based on the activation of the complement system which takes place via a classical and alternative route. Complement factor C4 participates in activation by the classical route. Human C4 forms a precipitate with a specific antiserum which is determined turbidimetrically.
Here's an analysis of the provided information regarding the acceptance criteria and study for the Tina-quant Complement C4 ver.2 Test System:
This document is a 510(k) summary for a diagnostic test, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results and acceptance criteria in the same way one might find for a novel therapeutic device. Therefore, some of the requested information (like expert qualifications, adjudication methods, MRMC studies, and detailed ground truth for training) is not explicitly present or directly applicable in this type of submission.
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated for substantial equivalence to a predicate device, focusing on analytical performance rather than a specific clinical outcome with acceptance criteria. The "acceptance criteria" here are implied by the comparison to the predicate's performance specifications.
| Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Modified Tina-quant Complement C4 ver.2) | Explanation/Comment |
|---|---|---|
| Intended Use | In vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative immunological determination of human complement C4 in serum and plasma. | The intended use is identical to the predicate device, indicating substantial equivalence in this aspect. |
| Indication for Use | Aid in detecting the presence and level of C4 found in autoimmune diseases, infections and inflammatory disorders. | The indication for use is identical to the predicate device, indicating substantial equivalence in this aspect. |
| Analyzer | COBAS Integra analyzers | The analyzer is identical to the predicate device, indicating substantial equivalence in this aspect. |
| Sample Type | Human serum and plasma | The modified device expands the sample type to include "plasma" in addition to "human serum" used by the predicate. This is a modification but considered substantially equivalent as assays often perform similarly on serum and plasma for many analytes. |
| Analytical Sensitivity (Predicate K951595): 0.012 g/L (1.2 mg/dL) | Analytical Sensitivity (Modified Device): 0.04 g/L (4 mg/dL) | The modified device has a higher analytical sensitivity (i.e., a less sensitive detection limit) than the predicate. This is a change, but likely deemed acceptable within the context of clinical utility and substantial equivalence. The document doesn't provide a specific acceptance criterion for deviation from the predicate's sensitivity, but typically a less sensitive assay would need to retain clinical validity for its intended use. |
| Measuring Range (Predicate K951595): 0.06-0.9 g/L (6-90 mg/dL) | Measuring Range (Modified Device): 0.04-1.35 g/L (4-135 mg/dL) | The modified device has a wider measuring range (both lower and higher than the predicate). This is generally a beneficial change, indicating improved analytical capability, assuming accuracy and precision are maintained across this wider range. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly state the sample size used for any specific test set related to validation studies. It focuses on the descriptive comparison to the predicate device.
The data provenance is not specified. For in vitro diagnostic devices, studies typically involve human serum and/or plasma samples, which could be collected prospectively or retrospectively from various geographical locations. However, this detail is not present in the summary.
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 510(k) summary. For a diagnostic test like C4, the "ground truth" for analytical performance (sensitivity, measuring range) is established through laboratory methods and reference materials, not typically by expert interpretation of individual cases. If clinical correlation studies were performed, expert medical opinion might be involved, but this document does not detail such studies.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary, as it's not relevant for demonstrating analytical performance through comparison to a predicate device. Adjudication methods are typically used in studies involving human interpretation or subjective assessments.
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, nor would it be expected for this type of in vitro diagnostic device (a quantitative immunological assay for C4). MRMC studies are typically performed for imaging devices or other tools where human readers interpret complex data.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the testing described implicitly represents a "standalone" performance evaluation. The Tina-quant Complement C4 ver.2 Test System is an automated in vitro diagnostic assay. Its performance (analytical sensitivity, measuring range, etc.) is measured directly by the instrument, without human interpretation of the primary data output. Human "in-the-loop" would involve clinicians interpreting the numerical results, but the device's performance itself is standalone.
7. The Type of Ground Truth Used
For the analytical performance metrics (analytical sensitivity, measuring range), the ground truth is established through:
- Reference materials/calibrators: Known concentrations of C4 used to calibrate the assay and determine its range.
- Performance characteristics of the predicate device: The predicate's established performance serves as the benchmark against which the modified device is compared to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
The provided 510(k) summary does not specify a "training set" size. For an in vitro diagnostic assay, development and optimization would involve various samples, but this is distinct from "training data" in artificial intelligence/machine learning contexts.
9. How the Ground Truth for the Training Set Was Established
Since a "training set" as understood in AI/ML is not applicable here, the method of establishing ground truth for it is also not applicable. The development and validation of an IVD assay involve rigorous analytical studies with characterized samples and reference materials to establish its performance specifications.
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NOV 2 9 2001 510(k) Summary According to the requirements established in the Food and Drug Introduction Administration's guidance document entitled "The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications", the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. Roche Diagnostics Corporation 1) Submitter name, address, 9115 Hague Rd. Indianapolis, IN 46250 contact (317) 521-7643 Contact Person: Helen T. Torney Date Prepared: July 23, 2001 Tina-quant Complement C4 Test System Proprietary name: 2) Device name Complement C4 Test Common name: Classification name: Complement components immunological test system. We claim substantial equivalence to the currently marketed Tina-quant 3) Predicate Complement C4 Test System on Roche COBAS Integra Analyzers device (K951595)
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510(k) Summary, Continued
| 4) DeviceDescription | The Tina-quant Complement C4 Test System is based on the activation of thecomplement system which takes place via a classical and alternative route.Complement factor C4 participates in activation by the classical route.Human C4 forms a precipitate with a specific antiserum which is determinedturbidimetrically. |
|---|---|
| 5) Intended use | In vitro diagnostic reagent system intended for use on COBAS INTEGRAsystems for the quantitative immunological determination of humancomplement C4 in serum and plasma. |
| 6.) Substantialequivalence | The table below indicates the similarities between the modified Tina-quantComplement C4 ver.2 Test System on COBAS Integra analyzers and thepredicate, Tina-quant Complement C4 Test System Roche (K951595). Insummary, the Tina-quant Complement C4 ver.2 Test System described in thissubmission is, in our opinion, substantially equivalent to the predicate device. |
submission is, in our opinion, substantially equivalent to
| Topic | ModifiedTina-quant Complement C4 ver. | Tina-quant Complement C4(cleared K951595) |
|---|---|---|
| Intended Use | In vitro diagnostic reagent systemintended for use on COBASINTEGRA systems for thequantitative immunologicaldetermination of humancomplement C4 in serum andplasma | For the in vitro quantitativeimmunological determination ofhuman complement C4 in serum andplasma. |
| Indication for Use | Aid in detecting the presence andlevel of C4 found in autoimmunediseases, infections andinflammatory disorders. | Aid in detecting the presence andlevel of C4 found in autoimmunediseases, infections andinflammatory disorders. |
| Analyzer | COBAS Integra analyzers | COBAS Integra analyzers |
| Sample Type | Human serum and plasma | Human serum |
| Analytical Sensitivity | 0.04 g/L (4 mg/dL) | 0.012 g/L (1.2mg/dL) |
| Wavelength | 340/659 nm | 340/659 nm |
| Measuring Range | 0.04-1.35 g/L(4-135 mg/dL) | 0.06-0.9 g/L(6-90 mg/dL) |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 2 9 2001
Ms. Helen Torney Centralized Diagnostics Regulatory Submissions Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K012359
Trade/Device Name: Tina-Quant Complement C4 ver.2 Test System Regulation Number: 21 CFR 866.5240 Regulation Name: Complement components immunological test system Regulatory Class: Class II Product Code: DBI Dated: October 12, 2001 Received: October 15, 2001
Dear Ms.Torney:
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.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anon-you 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (301) 594-4560. I readers of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mornlactor on Jour responsible 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,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): V(012359 Device Name: Tina-quant Complement C4 ver.2 Test System
Indications for Use:
In vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the In viti o diagnostic reague of buman complement C4 in serum and plasma. qualificative inimulations and level of C4 found in autoimmune diseases, infections and inflammatory disorders.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Seisen Altare
sion of Clinical Laboratory Devices
510(k) Number_Kol 2359
Prescription Use V (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 866.5240 Complement components immunological test system.
(a)
Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.(b)
Classification. Class II (performance standards).