(54 days)
PreciControl Troponia T is used for quality control of the Elecsys Troponin T (CARDIAC T) immunoassay of the Elecsys immunoassay systems.
The Elecsys PreciControl Troponin T is a lyophilized manufactured using recombinant human Troponia T in human serum matrix. The analyte is spiked into the matrix to the correct concentration levels.
The provided text does not contain detailed information about the acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) summary for a medical device called "Elecsys® PreciControl Troponin T," which is a calibration verification material used for quality control of the Elecsys Troponin T immunoassay.
The primary purpose of this 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to detail comprehensive performance studies with specific acceptance criteria and outcome metrics for standalone device performance or human-in-the-loop studies.
Here's an analysis based on the lack of the requested information in the provided text:
1. A table of acceptance criteria and the reported device performance
- Information not provided. The document states the intended use of the device and compares it to a predicate device, noting they are for the same purpose (quality control of immunoassays). It does not present specific quantitative acceptance criteria or performance metrics for the Elecsys® PreciControl Troponin T itself.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information not provided. There is no mention of a test set, sample size, or data provenance for any performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Information not provided. Since this is a quality control material and not a diagnostic device interpreting patient data, the concept of "experts establishing ground truth for a test set" in the context of clinical images or patient outcomes doesn't directly apply. The ground truth for a quality control material would typically be its manufacturing-determined analyte concentration values, which are then used to verify the performance of the immunoassay. No details on this process are given.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Information not provided. No test set or related adjudication process is described.
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 a quality control material, not an AI or imaging device involving human readers. Therefore, an MRMC study or AI assistance is irrelevant to its function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical material (lyophilized recombinant human Troponia T in human serum matrix) used for quality control, not an algorithm. Therefore, "standalone algorithm performance" is not relevant. The performance of the quality control material itself would be assessed through its stability, accuracy of target values, and precision, but these details are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Information not provided explicitly. For a quality control material, the "ground truth" usually refers to the assigned values or target concentrations of the analytes within the control material, established during its manufacturing and characterization. These values are then used to verify the accuracy of diagnostic assays. The document doesn't detail how these "true" or "assigned" values for the Elecsys® PreciControl Troponin T were established.
8. The sample size for the training set
- Not applicable/Information not provided. As this is not an AI or machine learning device, there is no "training set."
9. How the ground truth for the training set was established
- Not applicable/Information not provided. As there is no training set, this question is not relevant.
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Revised 8/14/03
AUG 2 0 2003
510(k) Summary
According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. の 2007年 10月 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 Roche Diagnostics Corporation Submitter name, address, 9115 Hague Road contact Indianapolis, IN 46250 (317) 521 - 3723 Contact Person: Kay Taylor (for Theresa M. Ambrose) Date Prepared: August 14, 2003 And And And And And And And Commend Commend Comments of Comments of Comments of Comments of Comments of Comments of Comments of Comments of Comments of Comments of Comments o Proprietary name: Elecsys® PreciControl Troponin T Device Name Common name: Calibration Verification Material Classification name: Single (specified) analyte controls (assayed and unassayed) and the state of the state of the state of the state of the first and the The Elecsys PreciControl Troponin T is substantially equivalent to the Predicate Device currently marketed Elecsys PreciControl Cardiac (K983492). Device The Elecsys PreciControl Troponin T is a lyophilized manufactured using Description recombinant human Troponia T in human serum matrix. The analyte is spiked into the matrix to the correct concentration levels.
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510(k) Summary, Continued
| Intended use | The Elecsys® PreciControl Troponin T is used for quality control of theElecsys Troponin T (Cardiac T®) immunoassay on the Elecsys immunoassaysystem. |
|---|---|
| Comparison topredicatedevice | The Elecsys® PreciControl Troponin T is substantially equivalent to otherproducts in commercial distribution intended for similar use. Most notably, itis substantially equivalent to the currently marketed Elecsys® PreciControlCardiac (K983492).The intended use of both devices are the same; as they are both intended foruse as the quality control of Elecsys® immunoassays. The proposed productis a single-analyte version of the multi-analyte predicate device. |
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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 and Human Services (HHS). The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is surrounded by the words "U.S. Department of Health & Human Services" in a circular arrangement.
Public Health Service
AUG 2 0 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Theresa M. Ambrose, Ph.D., FACB Regulatory Principal Centralized Diagnostics Regulatory Submissions Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250
Re: K031990
Trade/Device Name: Elecsys® PreciControl Troponin T Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: June 25, 2003 Received: June 27, 2003
Dear Dr. Ambrose:
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 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).
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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.
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,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Revised &/14/03
Indications for Use Statement
510(k) Number (if known): N/A
Device Name:
Elecsys PreciControl Troponin T
Indications For Use:
PreciControl Troponia T is used for quality control of the Elecsys Troponin T (CARDIAC T) immunoassay of the Elecsys immunoassay systems.
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
Carol C. Benum / B. Jean Cooper, DVM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K031990
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.