(27 days)
The Elecsys SHBG CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys SHBG quantitative assay reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only.
The Elecsys SHBG CalCheck 5 is a lyophilized product consisting of SHBG in human and equine (horse) serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
Here's an analysis of the provided text regarding the Elecsys SHBG CalCheck 5, focusing on acceptance criteria and study details:
The provided documents primarily constitute a 510(k) summary for the Elecsys SHBG CalCheck 5. This type of submission to the FDA focuses on establishing substantial equivalence to a predicate device, rather than proving a device's effectiveness through extensive clinical trials with specific acceptance criteria like those commonly seen for diagnostic AI/ML products.
Therefore, the information regarding acceptance criteria and study design for validating diagnostic performance (like sensitivity, specificity, accuracy against a gold standard) is not present in the provided text, as this is not the nature of a 510(k) for a quality control material.
The data provided describes the evaluation of the CalCheck 5 for value assignment and performance characteristics stability, which are internal validation steps for a quality control product, not a diagnostic device.
Here's an attempt to answer your questions based on the available information, noting the limitations:
Acceptance Criteria and Study Details for Elecsys SHBG CalCheck 5
Given that the Elecsys SHBG CalCheck 5 is an assayed control for calibration verification, its "acceptance criteria" are intrinsically linked to its intended use: to accurately verify the assay range and calibration of the Elecsys SHBG quantitative assay. The studies conducted are internal validations of the control material itself, rather than diagnostic performance studies.
1. A table of acceptance criteria and the reported device performance
Based on the provided text, specific numerical acceptance criteria (e.g., within certain percentage of target value, stability limits) are not detailed. The "reported device performance" is described as the evaluation for "value assignment and Performance Characteristics stability," but the specific outcomes or thresholds are not presented in this summary.
| Characteristic | Acceptance Criteria (Not explicitly stated in summary) | Reported Device Performance (Implied from the study purpose) |
|---|---|---|
| Value Assignment | (Likely: Values fall within specific target ranges for each check level) | Evaluated for value assignment. (Specific data not provided.) |
| Stability | (Likely: Maintains stated concentrations over specified storage conditions and timeframes) | Evaluated for Performance Characteristics stability. (Specific data not provided.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. For a quality control material, this typically refers to the number of lots produced and tested, or the number of replicates in internal validation studies.
- Data Provenance: Not specified. Given it's an internal validation for a quality control material, the data would likely originate from Roche Diagnostics' manufacturing and R&D facilities. The nature would be prospective, as it involves testing newly manufactured product.
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)
This question is not applicable to this type of device. As a quality control material, "ground truth" doesn't involve clinical diagnosis by expert human readers. The "truth" for this device would be its assigned SHBG concentration, which is determined through rigorous analytical methods by the manufacturer.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are relevant for subjective interpretations (e.g., image reading) where disagreement among experts needs resolution. For a quantitative analytical control, the "truth" is analytically derived, not adjudicated by experts.
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 question is not applicable.
- This device is not an AI/ML diagnostic tool; it's a quality control material for an immunoassay.
- It does not involve human "readers" in the context of interpretation, nor does it involve AI assistance.
- Therefore, an MRMC comparative effectiveness study is not relevant to its validation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The device is not an algorithm, but a physical reagent (lyophilized control material).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the Elecsys SHBG CalCheck 5 is its assigned concentration of SHBG. This is established through highly precise and accurate analytical methods (e.g., using reference methods, internal standards, and extensive characterization studies) by the manufacturer, Roche Diagnostics. It is not based on expert consensus, pathology, or outcomes data, as those relate to clinical diagnosis, not the characterization of a control material.
8. The sample size for the training set
This question is not applicable in the context of an algorithm or AI model. For a quality control material, there isn't a "training set" in this sense. The development of the control material involves formulation, stability studies, and value assignment, but not an algorithm training process.
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as point 8. The "ground truth" (assigned SHBG concentrations) for the control material is established through internal analytical validation and quality control procedures during manufacturing, not through a "training set" for an algorithm.
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KI1349
| 510(k) Summary | JUN - 9 2011 |
|---|---|
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
| Submittername, address,contact | Roche Diagnostics9115 Hague Road, P.O. Box 50416Indianapolis, IN 46250-0416317-521-3577 |
| Contact Person: Kelly FrenchPhone: 317-521-3208Fax: 317-521-2324Email: kelly.french@roche.com | |
| Secondary Contact: Stephanie GreemanPhone: 317-521-2458Fax: 317-521-2324Email: stephanie.greeman@roche.com | |
| Date Prepared: May 11, 2011 | |
| Device Name | Proprietary name: Elecsys SHBG CalCheck 5Common name: SHBG CalCheck 5Classification name: Single (specified) analyte controls (assayed andunassayed) |
| Predicatedevice | The Elecsys SHBG CalCheck 5 is substantially equivalent to other productsin commercial distribution intended for similar use. We claim equivalency tothe currently marketed SHBG CalCheck (K031698). |
| DeviceDescription | The Elecsys SHBG CalCheck 5 is a lyophilized product consisting of SHBGin human and equine (horse) serum matrix. During manufacture, the analyteis spiked into the matrix at the desired concentration levels. |
| Intended use | The Elecsys SHBG CalCheck 5 is an assayed control for use in calibrationverification and for use in the verification of the assay range established bythe Elecsys SHBG quantitative assay reagent on the indicated Elecsys andcobas e immunoassay analyzers, for in vitro diagnostic use only. |
| Continued on next page |
510(k) Summary
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510(k) Summary, Continued
Comparison Table
The table below compares Elecsys SHBG CalCheck 5 with the predicate device, Elecsys SHBG CalCheck (K031698). The predicate shows that SHBG CalCheck 5 is substantially equivalent to SHBG CalCheck, with several key similarities, especially the analyte. The shaded fields indicate similar characteristics between the candidate device and the predicate device.
| Characteristic | Elecsys SHBGCalCheck 5(Candidate Device) | Elecsys SHBG CalCheck(K031698) |
|---|---|---|
| Intended Use | The Elecsys SHBGCalcheck 5 is an assayedcontrol for use incalibration verification andfor use in the verificationof the assay rangeestablished by the ElecsysSHBG quantitative assayreagent on the indicatedElecsys and cobas eimmunoassay analyzers. | For use in the verification ofthe calibration established bythe Elecsys SHBG regent onElecsys1010/2010/MODULARANALYTICS E170immunoassay analyzers. |
| Analyte | SHBG | SHBG |
| Levels | Five | Three |
| Assay MeasuringRange | $0.800-200$ nmol/L | $0.350 - 200$ nmol/L |
| Check TargetValues | Check 1: $< 5$ nmol/LCheck 2: $20$ nmol/LCheck 3: $80$ nmol/LCheck 4: $150$ nmol/LCheck 5: $200$ nmol/L | Check 1: $20$ nmol/LCheck 2: $80$ nmol/LCheck 3: $150$ nmol/L |
| Format | Lyophilized | Lyophilized |
| Handling | Reconstitute Check 1,Check 2, Check 3, Check4, and Check 5 withexactly 1.0 mL distilled ordeionized water. Allow tostand closed for 15minutes, then mix gentlyby inversion. | Reconstitute Check 1, Check2, and Check 3 with exactly1.0 mL distilled or deionizedwater. Allow to stand closedfor 15 minutes, then mixgently by inversion. |
| Stability | Unopened:• Store at 2-8°C untilexpiration dateReconstituted:• 20-25°C: 4 hours | Unopened:• Store at 2-8°C untilexpiration dateReconstituted:• 20-25°C: 4 hours |
| Matrix | Human serum/Horseserum matrix | Human serum/Horse serummatrix |
Continued on next page
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510(k) Summary, Continued
The Elecsys SHBG CalCheck 5 was evaluated for value assignment and Performance Characteristics stability.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract emblem featuring three stylized lines, resembling an eagle or bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Roche Diagnostics c/o Ms. Kelly French Manager, Regulatory Affairs 9115 Hague Road, PO Box 50416 Indianapolis, IN 46250-0416
JUN - 9 2011
Re: K111349 Trade Name: Elecsys SHBG CalCheck 5 Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed). · Regulatory Class: Class I, reserved . Product Codes: JJX Dated: May 12, 2011 Received: May 13, 2011
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
CJC.
Courtney Harper, 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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Indication for Use
510(k) Number (if known):
Device Name: Elecsys SHBG CalCheck 5
Indication For Use:
The Elecsys SHBG CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys SHBG reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ י (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 (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K111349
§ 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.