(127 days)
For the in vitro quantitative immunological determination of human complement C3c in serum and plasma. Measurements of these proteins aid in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.
The Tina-quant Complement C3c ver.2 Test System is based on the activation of the complement system which takes place via a classical and an alternative route. The two pathways come together in a joint terminal path. As a complement factor C3 is a factor common to both pathways, the concentration of C3 and its degradation products (including C3c) can be evaluated as a parameter for activation of the complement system. Human C3c forms a precipitate with a specific antiserum which is determined turbidimetrically.
The provided text describes a 510(k) summary for the Tina-quant Complement C3c ver.2 Test System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a new device meets specific acceptance criteria through a novel study. Therefore, much of the requested information (like sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance studies, and training set details) is not typically included in a 510(k) summary focused on substantial equivalence for an in vitro diagnostic (IVD) device like this one.
However, I can extract the relevant information regarding the acceptance criteria (as implied by comparison to the predicate) and the reported device performance.
1. Table of Acceptance Criteria and Reported Device Performance
For IVD devices seeking 510(k) clearance, the "acceptance criteria" are generally that the new device's performance characteristics demonstrate substantial equivalence to the predicate device. This is shown by comparing key analytical performance parameters.
| Performance Characteristic | Acceptance Criteria (Predicate Device K951595) | Reported Device Performance (Tina-quant Complement C3c ver.2) |
|---|---|---|
| Intended Use | For the in vitro quantitative immunological determination of human complement C3c in serum. | For the in vitro quantitative immunological determination of human complement C3c in serum and plasma. |
| Indication for Use | Measurements of these proteins aid in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components. | Measurements of these proteins aid in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components. |
| Sample Type | Human serum | Human serum and plasma |
| Analytical Sensitivity | 0.262 g/L (26 mg/dL) | 0.11 g/L (11 mg/dL) |
| Wavelength | 340/659 nm | 340/659 nm |
| Analyzer | COBAS Integra analyzers | COBAS Integra analyzers |
| Measuring Range | 0.55-8.9 g/L (55-890 mg/dL) | 0.11-6.0 g/L (11-600 mg/dL) |
Study Description:
The study proving the device meets the acceptance criteria (i.e., demonstrates substantial equivalence) is a comparison study against the predicate device, Tina-quant Complement C3c Test System (K951595). The summary states: "The table below indicates the similarities between the modified Tina-quant Complement C3c ver.2 Test System on COBAS Integra analyzers and the predicate, Tina-quant Complement C3c Test System on COBAS Integra analyzers (K951595). In summary, the Tina-quant Complement C3c ver.2 Test System described in this submission is, in our opinion, substantially equivalent to the predicate device."
This comparison highlights that the new device has a broader sample type (includes plasma) and improved analytical sensitivity (lower detection limit) compared to the predicate, while maintaining the same intended use (with expanded sample type), indications for use, wavelength, and analyzer. The measuring range has also shifted to a lower limit, providing a broader range at the lower end.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. For IVD devices comparing performance to a predicate, studies would typically involve a sufficient number of patient samples to demonstrate equivalent or improved performance across various concentrations and clinical conditions. However, the exact number is not detailed in this summary.
- Data Provenance: Not explicitly stated. Given it's a product performance comparison, the data would likely be from laboratory testing. It's not specified if it's retrospective or prospective, nor the country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable and not included in the provided 510(k) summary. For an IVD device measuring an analyte concentration, "ground truth" is typically established through reference methods, calibrated standards, or validated internal procedures, rather than expert consensus on diagnostic images or clinical outcomes.
4. Adjudication method for the test set:
- Not applicable and not included. Adjudication methods like "2+1" or "3+1" are relevant for performance studies where human interpretation of medical images or other complex data is being assessed, often with multiple readers. For an automated IVD test measuring an analyte, this type of adjudication is not part of the performance evaluation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an automated in vitro diagnostic test for measuring an analyte (Complement C3c concentration). It does not involve human readers interpreting images, nor does it incorporate AI assistance for diagnostic interpretation. Therefore, an MRMC study or AI-related effectiveness is irrelevant for this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, implicitly. The device itself is an automated laboratory analyzer for quantitative immunological determination. Its performance is inherently "standalone" in the sense that it provides a quantitative measurement directly, without requiring human interpretation during the measurement process. The study compares the performance characteristics of this automated system to its predicate, also an automated system.
7. The type of ground truth used:
- The "ground truth" for this type of IVD device is generally based on the accurate measurement of the analyte (human complement C3c) using established reference methods, calibrated standards, and quality control materials. The summary does not explicitly state the reference method used to establish the "truth" for the samples tested, but it is implied to be analytical accuracy and precision determined through standard laboratory practices for IVD validation.
8. The sample size for the training set:
- Not applicable. This device is a quantitative immunoassay test system, not a machine learning or AI-based algorithm that requires a "training set" in the computational sense. Its performance is based on the chemical and immunological reactions and the associated detection system.
9. How the ground truth for the training set was established:
- Not applicable for the same reasons as #8.
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NOV 2 9 2001
510(k) Summary
| Introduction | According to the requirements established in the Food and DrugAdministration's guidance document entitled "The New 510(k) Paradigm:Alternate Approaches to Demonstrating Substantial Equivalence in PremarketNotifications", the following information provides sufficient detail tounderstand the basis for a determination of substantial equivalence. |
|---|---|
| 1) Submittername, address,contact | Roche Diagnostics Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 576-7643Contact Person: Helen T. TorneyDate Prepared: November 12, 2001 |
| 2) Device name | Proprietary name: Tina-quant Complement C3c Test SystemCommon name: Complement C3c TestClassification name: Complement components immunological test system |
| 3) Predicatedevice | We claim substantial equivalence to the currently marketed Tina-quantComplement C3c Test System on Roche COBAS Integra Analyzers(K591595). |
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510(k) Summary, Continued
| 4) DeviceDescription | The Tina-quant Complement C3c ver.2 Test System is based on the activationof the complement system which takes place via a classical and an alternativeroute. The two pathways come together in a joint terminal path. As acomplement factor C3 is a factor common to both pathways, theconcentration of C3 and its degradation products (including C3c) can beevaluated as a parameter for activation of the complement system. HumanC3c forms a precipitate with a specific antiserum which is determinedturbidimetrically. |
|---|---|
| 5) Intended use | For the in vitro quantitative immunological determination of humancomplement C3c in serum and plasma. |
| 6.) Substantialequivalence | The table below indicates the similarities between the modified Tina-quantComplement C3c ver.2 Test System on COBAS Integra analyzers and thepredicate, Tina-quant Complement C3c Test System on COBAS Integraanalyzers (K951595). In summary, the Tina-quant Complement C3c ver.2Test System described in this submission is, in our opinion, substantiallyequivalent to the predicate device.Comparison of Proposed and Predicate Device |
| Topic | ModifiedTina-quantComplement C3c ver.2 | Tina-quant Complement C3c(cleared K951595) |
|---|---|---|
| Intended Use | For the in vitroquantitativeimmunologicaldetermination of humancomplement C3c in serumand plasma. | For the in vitro quantitativeimmunological determination ofhuman complement C3c in serum. |
| Indication for Use | Measurements of theseproteins aid in thediagnosis of immunologicdisorders, especially thoseassociated withdeficiencies ofcomplement components. | Measurements of these proteins aidin the diagnosis of immunologicdisorders, especially those associatedwith deficiencies of complementcomponents. |
| Sample Type | Human serum and plasma | Human serum |
| Analytical Sensitivity | 0.11 g/L (11 mg/dL) | 0.262 g/L (26mg/dL) |
| Wavelength | 340/659 nm | 340/659 nm |
| Analyzer | COBAS Integra analyzers | COBAS Integra analyzers |
·
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| Topic | ModifiedTina-quantComplement C3c ver.2 | Tina-quant Complement C3c(cleared K951595) |
|---|---|---|
| Measuring Range | 0.11-6.0 g/L (11-600mg/dL) | 0.55-8.9 g/L (55-890 mg/dL) |
.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal 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: K012361
Trade/Device Name: Tina-Quant Complement C3c ver.2 Test System Regulation Number: 21 CFR 866.5240 Regulation Name: Complement components immunological test system Regulatory Class: Class II Product Code: CZW Dated: November 12, 2001 Received: November 14, 2001
Dear Ms. Torney:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection b retar pe issubstantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreativent of the enactment date of the Medical Device Amendments, or to commence phor to May 20, 1978, in example with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). alla Cosmetic Act (1101) that do not request of the general controls provisions of the Act. The T ou may, dicrerere, mains of the Act include requirements for annual registration, listing of general controls provisions of vactice, 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 IT your device is olassified (600 as controls. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may ou found in the Overnments concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be devisou that I Dr unation that your device complies with other requirements of the Act that I DTT has made a actern regulations administered by other Federal agencies. You must or any I catales and regisments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of A rate 6075, accems (21 CFR Part 820); and if applicable, the electronic forth in the quind) byers provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 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, please contact the Office 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 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/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Gutman
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): KOI236 | Device Name: Tina-quant Complement C3c ver.2 Test System
Indications for Use:
For the in vitro quantitative immunological determination of human complement C3cin serum and plasma. Measurements of these proteins aid in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan S. Altare
vision Sign-Off) vision of Clineal Laboratory Devices
510(k) Number K012361
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).