(28 days)
The Elecsys TSH CalSet is used for calibrating the quantitative Elecsys TSH assay on the Elecsys immunoassay analyzers.
The Elecsys TSH CalSet consists of equine serum matrix (Cal 1) and a human serum matrix with human TSH (Cal 2) in two concentration ranges. The Elecsys TSH CalSet is supplied in ready for use liquid format.
This 510(k) summary (K060754) for the Elecsys TSH CalSet provides limited information regarding specific performance studies and acceptance criteria typically found for diagnostic devices. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (Elecsys TSH CalSet K961491) rather than presenting detailed performance data from a new clinical study.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state acceptance criteria or report specific device performance metrics in the format of a table with numerical values for sensitivity, specificity, accuracy, etc. This type of information is generally expected for diagnostic devices that analyze patient samples.
The comparison table in the 510(k) summary focuses on device features of the modified Elecsys TSH CalSet versus the predicate, such as intended use, traceability, levels, storage form, matrix, stability, and target concentrations. These are design and manufacturing specifications, not performance metrics against clinical outcomes or a ground truth.
For example, it states "Stability: Unopened... at 2-8°C up to the stated expiration date," and "Opened... after opening in aliquots at 2-8°C for 12 weeks." While these are important characteristics, they are not performance metrics like accuracy or precision.
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention any specific sample size for a test set or provide details on data provenance (e.g., country of origin, retrospective or prospective data). The submission is for a calibrator, which is used to standardize an assay, not to directly diagnose patients from a test set of patient samples. Therefore, a "test set" in the traditional sense of patient samples for diagnostic performance evaluation is not detailed here.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable or provided in the context of this 510(k) submission. A calibrator's "ground truth" relates to its traceable concentration values, not to interpretations by medical experts. The document states "Assay standardized against the 2nd IRP WHO reference standard 80/558," which indicates traceability to an international reference standard, not ground truth established by medical experts for diagnostic outcomes.
4. Adjudication Method
This information is not applicable or provided. Adjudication methods are used to resolve discrepancies among experts when establishing ground truth for diagnostic studies using patient data. Since this submission is for a calibrator and does not involve patient diagnoses or expert interpretation, adjudication is not relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not conducted and is not mentioned. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., imaging devices) to assess the impact of AI assistance on human reader performance. As the Elecsys TSH CalSet is a chemical calibrator for an automated immunoassay, human readers are not directly involved in its function or interpretation in a way that would necessitate an MRMC study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study, as typically understood for diagnostic algorithms, was not conducted and is not mentioned. The Elecsys TSH CalSet itself is a physical calibrator used within an automated immunoassay system. Its performance relates to its ability to correctly set the assay's measurement scale, which is typically evaluated through analytical studies (e.g., precision, accuracy, linearity) of the overall assay system when calibrated. The document implies that the performance of the assay itself (when calibrated with the device) is acceptable, but does not detail studies specifically for the calibrator's standalone performance in isolation.
7. Type of Ground Truth Used
The ground truth used for the Elecsys TSH CalSet is based on international reference standards and defined concentrations. The document explicitly states: "Assay standardized against the 2nd IRP WHO reference standard 80/558." This refers to a recognized international reference for TSH measurements, which provides the basis for establishing the "true" concentration values of the calibrator.
8. Sample Size for the Training Set
The document does not mention a training set sample size. This is because the Elecsys TSH CalSet is a chemical reagent (calibrator), not an AI algorithm or a diagnostic model that requires a training set in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set for an AI algorithm or diagnostic model, the method for establishing its ground truth is not applicable or provided. The "ground truth" for the calibrator's stated concentrations is established through reference to the 2nd IRP WHO reference standard 80/558, as mentioned above.
In summary:
This 510(k) submission for the Elecsys TSH CalSet focuses on demonstrating substantial equivalence to a predicate calibrator by comparing manufacturing specifications and intended use. It does not contain detailed performance studies or acceptance criteria typical for diagnostic devices that interpret patient data. The "studies" implied are likely internal analytical validations of the calibrator's characteristics (e.g., stability, concentration accuracy) and its impact on the overall TSH assay, rather than clinical trials with patient cohorts.
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APE 1 8 2006
510(k) Summary - Elecsys TSH CalSet
| 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 |
|---|---|
| Submitter name, address, contact | Roche Diagnostics9115 Hague RdIndianapolis IN 46250(317) 521-3544Contact person: Kay A. TaylorDate prepared: March 17, 2006 |
| Device Name | Proprietary name: Elecsys TSH CalSetCommon name: CalibratorClassification name: Calibrator, Secondary |
| Device description | The Elecsys TSH CalSet consists of equine serum matrix (Cal 1) and a human serum matrix with human TSH (Cal 2) in two concentration ranges. The Elecsys TSH CalSet is supplied in ready for use liquid format. |
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510(k) Summary - Elecsys® TSH CalSet, continued
| Intended use | Elecsys TSH CalSet is used for calibrating the quantitative Elecsys TSHassay on the Elecsys immunoassay analyzers. | |
|---|---|---|
| PredicateDevice | The Elecsys TSH CalSet is equivalent to other devices legally marketed in theUnited States. We claim equivalence to the Elecsys TSH CalSet (K961491). | |
| DeviceComparison | The table below compares the device features of the Elecsys TSH CalSet(modified) and original (K961491). |
| Topic | Elecsys TSH CalSet(K961491) | Elecsys TSH CalSet(Modified Device) |
|---|---|---|
| Intended use | Used for calibrating the quantitativeElecsys TSH assay on the Elecsys2010 immunoassay analyzer. | Used for calibrating the quantitativeElecsys TSH assay on the Elecsysimmunoassay analyzers. |
| Traceability | Assay standardized against the 2nd IRPWHO reference standard 80/558 | Same |
| Levels | Two | Same |
| Storage Form | Liquid | Same |
| Matrix | Horse serum matrix with addedrecombinant TSH | Equine serum matrix with added TSH(human). |
| Stability | Unopened:ο at 2-8°C up to the statedexpiration date.Opened:ο 4 weeks at at 2-8°Cο on the analyzer up to a maximumof five hours in total. | Unopened:ο at 2-8°C up to the statedexpiration date.Opened:ο after opening in aliquots at 2-8°Cfor 12 weeks.ο on 1010/2010 at 20-25°C up to 5hoursο on E170 use only once. |
| TargetConcentrations | Cal 1: 0 µIU/mLCal 2: 1.5 µIU/mL | Same |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular logo with a stylized bird in the center. The bird has a long, curved neck and three wing-like shapes extending from its body. The bird is black, and the background is white. The text around the circle is not legible.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 1 3 2006
Ms. Kay A. Taylor Regulatory Affairs Principal Roche Diagnostics Corp. 9115 Haguc Road Indianapolis, IN 46250
Re: K060754 Trade/Device Name: Elecsys TSH CalSet Regulation Number: 21 CFR8862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: March 17, 2006 Received: March 21, 2006
Dear Ms. Taylor:
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 C FR 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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Page 2 -
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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Albert Gutt
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology 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): K060754
Device Name: Elecsys TSH CalSet
Indications For Use:
The Elecsys TSH CalSet is used for calibrating the quantitative Elecsys TSH assay on the Elecsys immunoassay analyzers.
Prescription Use XXXX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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.10(k) KCC234
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.