(30 days)
The Elecsys® Anti-Tg CalCheck is intended for use in the verification of the calibration established by the Elecsys® Anti-Tg reagent on Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.
The Elecsys® Anti-Tg CalCheck is a lyophilized product manufactured using a human serum base, human Anti-Tg, and preservative. The analyte is appropriately spiked into the CalCheck matrix to the correct concentration.
The provided document is a 510(k) summary for the Elecsys® Anti-Tg CalCheck, a calibration verification material. This type of device is a control material used to verify the calibration of an immunoassay analyzer and does not typically involve traditional "device performance" in terms of diagnostic accuracy metrics like sensitivity or specificity. Instead, the performance characteristics relevant to this device are related to its value assignment and stability. Therefore, some of the requested information (e.g., MRMC studies, number of experts for ground truth, adjudication methods) is not applicable to this type of medical device's evaluation.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the Elecsys® Anti-Tg CalCheck was evaluated for "value assignment and stability." While specific numerical acceptance criteria (e.g., ±X% deviation from target value) and detailed reported performance metrics are not explicitly provided in this 510(k) summary, the FDA's clearance indicates that these criteria were met during the submission's review.
| Evaluation Area | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Value Assignment | Accurate and consistent assignment of Anti-Tg concentration values. | Evaluated and determined to be acceptable for its intended use. |
| Stability | Maintains assigned Anti-Tg concentration values over its shelf life. | Evaluated and determined to be stable for its intended use. |
Note: For this type of device, the "performance" is about whether the control material provides the correct, stable values needed to verify the calibration of the primary diagnostic assay. The 510(k) summary confirms these evaluations were performed and found acceptable for clearance.
2. Sample Size Used for the Test Set and the Data Provenance
This information is not provided in the 510(k) summary. Given that it's a calibration verification material, the "test set" would likely refer to the number of lots or samples of the CalCheck material manufactured and tested. Data provenance (country of origin, retrospective/prospective) is also not detailed for this type of product.
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/not provided. For a calibration verification material, the "ground truth" would be established by reference methods or highly accurate analytical techniques to determine the true concentration of the analyte (Anti-Tg) in the control material. This is a characteristic determined by laboratory measurements, not human expert consensus.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers are interpreting images or clinical data to establish a ground truth, which is not relevant for the performance evaluation of a calibration verification material.
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
This information is not applicable. This device is a calibration verification material, not an AI-powered diagnostic tool for human interpretation. Therefore, MRMC studies and AI-assisted performance improvements are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The Elecsys® Anti-Tg CalCheck is a physical control material, not an algorithm. Its "performance" is inherent to its physical and chemical properties and how accurately it can verify the calibration of an immunoassay system.
7. The Type of Ground Truth Used
For a calibration verification material, the "ground truth" is typically established by:
- Reference methods: Highly accurate and precise analytical methods used to determine the true concentration of the analyte (Anti-Tg) within the control material.
- Traceability to an international standard: Ensuring the assigned values are directly comparable to recognized international reference materials.
The 510(k) summary describes the device as a "lyophilized product manufactured using a human serum base, human Anti-Tg, and preservative. The analyte is appropriately spiked into the CalCheck matrix to the correct concentration," implying that the concentrations are scientifically determined and assigned during manufacturing.
8. The Sample Size for the Training Set
This information is not applicable/not provided. Calibration verification materials do not involve "training sets" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided. (See points 7 and 8.)
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| MAR 6 2002 | ||
|---|---|---|
| 510(k) Summary | K020369 | |
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. | |
| Submittername, address, contact | Roche Diagnostics Corporation9115 Hague RoadIndianapolis, IN 46250(317) 521 - 3831 | |
| Contact Person: Sherri L Coenen | ||
| Date Prepared: February 1, 2002 | ||
| Device Name | Proprietary name: Elecsys® Anti-Tg CalCheck | |
| Common name: Calibration Verification Material | ||
| Classification name: Single (specified) analyte controls (assayed + unassayed) | ||
| Predicate device | The Elecsys® Anti-Tg CalCheck is substantially equivalent to the currently marketed Elecsys® TSH CalCheck (K963147). | |
| Device Description | The Elecsys® Anti-Tg CalCheck is a lyophilized product manufactured using a human serum base, human Anti-Tg, and preservative. The analyte is appropriately spiked into the CalCheck matrix to the correct concentration |
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510(k) Summary, Continued
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| Intended use | The Elecsys® Anti-Tg CalCheck is used in the verification of the calibration established by the Elecsys® Anti-Tg reagent on Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers. |
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| Comparison to predicate device | The Elecsys® Anti-Tg CalCheck is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Elecsys® TSH CalCheck (K963147). |
| Performance Characteristics | The Elecsys® Anti-Tg CalCheck was evaluated for value assignment and stability. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle's head and three wavy lines representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
6 2002
Ms. Sherri L. Coenen Regulatory Affairs, Centralized Diagnostics MAR Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
K020369 Trade/Device Name: Elecsys® Abti-Tg CalCheck Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: February 1, 2002 Received: February 4, 2002
Dear Ms. Coenen:
Re:
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 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 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, 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 Butman
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 Statement
510(k) Number (if known): KO2O369
Device Name: Elecsys® Anti-Tg CalCheck
Indications For Use:
Elecsys® Anti-Tg CalCheck calibration verification solutions comprise three levels low, mid, and high - each with a defined Anti-Tg concentration. The low solution concentration is near the lower detection limit of the assay. The middle solution is in the middle or at a clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range.
The Elecsys® Anti-Tg CalCheck is intended for use in the verification of the calibration established by the Elecsys® Anti-Tg reagent on Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Sousan S. Altuie
I I aboratory Devic n of Clinica
510(k) Number K020369
§ 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.