(64 days)
The Elecsys Toxo IgG CalCheck, as assayed calibrator control, is intended for use in the verification of the calibration established by the Elecsys Toxo IgG reagent on the Elecsys 2010, the MODULAR ANALYTICS E170, and cobas e immunoassay analyzers.
The Elecsys Toxo IgG CalCheck is a lyophilized product consisting of human anti-Toxo IgG antibodies in human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.
The provided text describes a 510(k) summary for the Elecsys Toxo IgG CalCheck device. It outlines the device's intended use, comparison to a predicate device, and indicates that performance characteristics were evaluated for value assignment and stability.
However, the document does not provide specific acceptance criteria or details of a study that explicitly proves the device meets those criteria in a quantitative manner. It states that "The Elecsys Toxo IgG CalCheck was evaluated for value assignment and stability," but the results of these evaluations, including the actual performance metrics or a comparison to predefined acceptance criteria, are not presented.
Therefore, much of the requested information cannot be extracted from the given text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states that the device was "evaluated for value assignment and stability," but it does not list any specific acceptance criteria (e.g., within-run precision, lot-to-lot consistency, stability limits) nor does it report the quantitative results of these evaluations.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be extracted. The document mentions evaluations but provides no details on sample sizes or data provenance.
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/Cannot be extracted. This device is a calibration check for an immunoassay, not an imaging or diagnostic device that typically relies on expert interpretation for ground truth. The "ground truth" for a calibrator would be its assigned value and its stability characteristics, which are determined through laboratory testing, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Cannot be extracted. Adjudication methods are relevant for studies where human interpretation is involved in establishing a ground truth or evaluating device output. This is not the type of device or study 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 laboratory control/calibrator, not an AI-powered diagnostic tool intended for human reader assistance. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the conventional sense. This is a laboratory reagent. Its "performance" is evaluated independently of human interpretation in its intended use. However, the document does not detail these standalone performance evaluations.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. As a calibrator, its "ground truth" would be established through robust analytical methods, often traceable to reference materials, to assign its value and confirm its stability and consistency. The document does not specify these methods.
8. The sample size for the training set
- Not applicable. This device is a calibrator, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As this is not a machine learning device, there is no training set or ground truth establishment in that context.
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FEB 1 2 2009
510(k) Summary
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 Diagnostics 9115 Hague Road Indianapolis, IN 46250 317-521-3208
Contact Person: Kelly French
Date Prepared: November 20, 2008
Device Name
Proprietary name: Elecsys Toxo IgG CalCheck
Common name: Toxo IgG CalCheck
Classification name: Single (specified) analyte controls (assayed and unassayed)
Predicate device
The Elecsys Toxo IgG CalCheck is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys C-Peptide CalCheck (K040157).
The Elecsys Toxo IgG CalCheck is a lyophilized product consisting of Device human anti-Toxo IgG antibodies in human serum matrix. During Description manufacture, the analytes are spiked into the matrix at the desired concentration levels.
For use in the verification of the calibration established by the Elecsys Toxo Intended use IgG reagent on the Elecsys and cobas e immunoassay analyzers.
Continued on next page
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510(k) Summary, Continued
The table below compares Elecsys Toxo IgG CalCheck with the predicate Comparison device, Elecsys C-Peptide Calcheck (K040157). Table and the comments of the comments of the comments of the contraction of the contribution of the contribution of the contribution of the contribution of the contribution of the
| Characteristic | Elecsys C- Peptide CalCheck(K040157) | Elecsys Toxo IgG CalCheck |
|---|---|---|
| Intended Use | For use in the verification of thecalibration established by theElecsys C-Peptide reagent on theElecsys and cobas e immunoassayanalyzers. | For use in the verification of thecalibration established by the ElecsysToxo IgG reagent on the Elecsys andcobas e immunoassay analyzers. |
| Levels | Three | Same |
| Format | Lyophilized | Same |
| Handling | Reconstitute with exactly 1.0 mLdistilled or deionized water andallow standing closed for 15minutes, then mixing gently. | Same |
| Stability | Unopened:• Store at 2-8°C until expirationdateReconstituted:• 20 - 25 °C : 4 hrs | Same |
| Matrix | equine serum matrix | Human serum |
Performance Characteristics The Elecsys Toxo IgG CalCheck was evaluated for value assignment and stability.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kelly French Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-3831
.
Re: K083655
Trade/Device Name: Elecsys Toxo IgG CalCheck Regulation Number: 21 CFR 862.1660 21 CFR 866.3780
Regulation Name: Quality control material (assayed and unassayed) Toxoplasma gondii serological reagents
FEB 1 2 2009
Regulatory Class: I, II Product Code: JJX, LGD Dated: December 9, 2008 Received: December 10, 2008
Dear Ms. French:
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 (OS) 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). 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/cdrh/dsma/dsmamain.html.
Sincerely yours,
Felly A. Uejinet, M.D., Ph.D.
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
K083653 510(k) Number (if known):
Device Name: Elecsys Toxo IgG CalCheck
Indication For Use:
The Elecsys Toxo IgG CalCheck, as assayed calibrator control, is intended for use in the verification of the calibration established by the Elecsys Toxo IgG reagent on the Elecsys 2010, the MODULAR ANALYTICS E170, and cobas e immunoassay analyzers.
ਮ Prescription Use (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
freddie hi. Poole
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K083653
§ 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.