(22 days)
The Elecsys Progesterone III 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 Progesterone III reagent on the indicated Elecsys and cobas e immunoassay analyzers.
The Elecsys Progesterone III CalCheck 5 is a lyophilized product consisting of 5 different levels of plant-derived Progesterone in a human serum matrix. It is traceable via ID-GC/MS (isotope dilution gas chromatography mass spectrometry) to highly purified progesterone by weight analogous to BCR-348R and ERM-DA347.
The provided text describes the Elecsys Progesterone III CalCheck 5, a control material, and studies conducted to demonstrate its stability. This is not a description of an AI/ML powered device, therefore some of the requested information (e.g. number of experts, adjudication methods, MRMC studies, standalone performance) is not applicable.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (for Stability Studies) | Reported Device Performance (as % Recovery or value) |
|---|---|
| Study 1: Open-Vial Stability | |
| CalCheck Level 1: < 0.15 ng/mL | The data support the package insert claim that reconstituted Progesterone III CalCheck 5 is stable up to 4 hours at 20-25°C. (Specific recovery values not provided) |
| CalCheck Level 2: 85-115% recovery of reference material value | The data support the package insert claim that reconstituted Progesterone III CalCheck 5 is stable up to 4 hours at 20-25°C. (Specific recovery values not provided) |
| CalCheck Levels 3-5: 90-110% recovery of reference material value | The data support the package insert claim that reconstituted Progesterone III CalCheck 5 is stable up to 4 hours at 20-25°C. (Specific recovery values not provided) |
| Study 2: Accelerated Stability | |
| CalCheck Level 1: ≤ 0.15 ng/mL | The accelerated stability model employed supports an initial shelf-life claim of 18 months when stored at 2-8°C. (Specific recovery values not provided) |
| CalCheck Level 2: 85-115% recovery of reference material value | The accelerated stability model employed supports an initial shelf-life claim of 18 months when stored at 2-8°C. (Specific recovery values not provided) |
| CalCheck Levels 3-5: 90-110% recovery of reference material value | The accelerated stability model employed supports an initial shelf-life claim of 18 months when stored at 2-8°C. (Specific recovery values not provided) |
Note: The text explicitly states that specific recovery values for "on-test recovery" were calculated as a percent of the reference value, and that the data "support" or the model "supports" the claims. However, the precise numerical results for these recoveries are not provided in the summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Open-Vial Stability: One Elecsys Progesterone III CalCheck 5 lot was evaluated in duplicate.
- Accelerated Stability: One Elecsys Progesterone III CalCheck 5 lot was evaluated in duplicate.
- Data Provenance: The studies were performed internally by Roche Diagnostics, presumably in Mannheim, Germany (registration number 9610126) or Penzberg, Germany (registration number 9610529), as these are the registered manufacturing sites. The data is prospective for these specific stability lots, as the studies are designed to test the stability of new product lots.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as the device is a quality control material and not an AI/ML diagnostic or prognostic device requiring expert interpretation for ground truth establishment. The "ground truth" for these studies is the performance of the freshly reconstituted reference material.
4. Adjudication Method for the Test Set
This is not applicable. The studies involve quantitative measurements of progesterone levels, which do not require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, this is not applicable. This is a stability study for a quality control material, not a comparative effectiveness study involving human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This is not applicable. The device is a control material, not an algorithm. The performance of the material is assessed using an immunoassay analyzer (cobas e 411).
7. The Type of Ground Truth Used
The ground truth for the stability studies is the performance of the freshly reconstituted reference material. This reference material is characterized against highly purified progesterone standards traceable via ID-GC/MS (isotope dilution gas chromatography mass spectrometry), analogous to BCR-348R and ERM-DA347. This provides a highly accurate and traceable "true" value against which the stability of the test materials is compared.
8. The Sample Size for the Training Set
This is not applicable. The device is a control material and does not involve AI/ML requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. The device does not have a training set. However, the value assignment process for each CalCheck lot involves running the CalChecks in duplicate on at least three cobas e 601 analyzers, with the assigned value being the mean of at least 6 determinations. This process also involves comparisons to other analyzer platforms (cobas e 411) to ensure consistency. The underlying traceability is to ID-GC/MS.
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May 1, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ROCHE DIAGNOSTICS ADAM CLARK REGULATORY AFFAIRS CONSULTANT 9115 HAGUE ROAD INDIANAPOLIS IN 46250
Re: K150955
Trade/Device Name: Elecsys Progesterone III CalCheck 5 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I. Reserved Product Code: JJX Dated: April 8, 2015 Received: April 9, 2015
Dear Mr. Clark:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2-Mr. Clark
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150955
Device Name Elecsys Progesterone III CalCheck 5
Indications for Use (Describe)
The Elecsys Progesterone III CalCheck 5 is an assayed control for use in callbration verification and for use in the verification of the assay range established by the Elecsys Progesterone III reagent on the indicated Elecsys and cobas e immunoassay analyzers.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary for the Elecsys Progesterone III CalCheck 5
| Introduction | According to the requirements of 21 CFR 807.92, the following information providesufficient detail to understand the basis for a determination of substantialequivalence. | ||
|---|---|---|---|
| SubmitterName,Address,Contact | Roche Diagnostics9115 Hague RoadP.O. Box 50416Indianapolis, IN 46250-0415Contact Person: Adam ClarkPhone: (317) 521-4371 Fax: (317) 521-2324 Email: adam.clark@roche.com Secondary Contact Person: Michael LeutherPhone: (317) 521-3930 Fax: (317) 521-2324 Email: michael.leuther@roche.com Date Prepared: April 27, 2015 | ||
| Purpose | In accordance with 21 CFR 807.87, Roche Diagnostics hereby submits officialnotification as required by Section 510(k) of the Federal Food, Drug and CosmeticsAct of our intention to market the device described in this Premarket Notification510(k).The purpose of this premarket notification is to obtain FDA review and clearance forthe Elecsys Progesterone III CalCheck 5. | ||
| Device Name | Proprietary name: | Elecsys Progesterone III CalCheck 5 | |
| Common name: | Progesterone III CalCheck 5 | ||
| Classification name: | 21 CFR 816.1660, Single (specified) analyte controls (assayedand unassayed) | ||
| Product Code: | JJX | ||
| Predicate Device: | Elecsys Estradiol III CalCheck 5 |
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Establishment For the Elecsys Progesterone III CalCheck 5, the establishment registration number Registration for Roche Diagnostics GmbH in Mannheim, Germany is 9610126, and for Penzberg, Germany is 9610529. The establishment registration number for Roche Diagnostics in the United States is 1823260.
Classification The FDA has classified the Elecsys Progesterone III CalCheck 5 as a Class I reserved device.
| Panel | Product Code | Classification Name | Regulation Citation |
|---|---|---|---|
| Clinical Chemistry (75) | JJX | Single (specified) analyte controls (assayed and unassayed) | 21 CFR 862.1660 |
Device Description Elecsys Progesterone III CalCheck 5:
- The Elecsys Progesterone III CalCheck 5 is a lyophilized product consisting of 5 different levels of plant-derived Progesterone in a human serum matrix. It is traceable via ID-GC/MS (isotope dilution gas chromatography mass spectrometry) to highly purified progesterone by weight analogous to BCR-348R and ERM-DA347.
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| Intended Use/Indicationsfor Use | The Elecsys Progesterone III CalCheck 5 is an assayed control for use in calibrationverification and for use in the verification of the assay range established by theElecsys Progesterone III reagent on the indicated Elecsys and cobas e immunoassayanalyzers. | |
|---|---|---|
| SubstantialEquivalence | The Elecsys Progesterone III CalCheck 5 is substantially equivalent to other productsin commercial distribution intended for similar use. We claim equivalency to thecurrently approved Elecsys Estradiol III CalCheck 5 (K142147). | |
| SubstantialEquivalence -Comparison | The table below compares Elecsys Progesterone III CalCheck 5 with the predicatedevice, Elecsys Estradiol III CalCheck 5 (K142147). | |
| Assay Comparison | ||
| Feature | Predicate Device:Elecsys Estradiol III CalCheck 5(K142147) | Candidate Device:Elecsys Progesterone III CalCheck 5 |
| General Assay Features | ||
| Intended Use/Indications forUse | The Elecsys Estradiol IIICalCheck 5 is an assayed controlfor use in calibration verificationand for use in the verification ofthe assay range established by theElecsys Estradiol III reagent onthe indicated Elecsys and cobas eimmunoassay analyzers. | The Elecsys Progesterone III CalCheck 5is an assayed control for use incalibration verification and for use in theverification of the assay rangeestablished by the Elecsys ProgesteroneIII reagent on the indicated Elecsys andcobas e immunoassay analyzers. |
| Analyte | Estradiol (Synthetic) | Progesterone (plant material) |
| Matrix | Human serum matrix | Human serum matrix |
| Levels | Five | Five |
| Assay MeasuringRange | 5 - 3000 pg/mL | 0.05 - 60 ng/mL |
| Check TargetValues | Check 1: ≤ 10 pg/mLCheck 2: 100 pg/mLCheck 3: 1500 pg/mLCheck 4: 2400 pg/mLCheck 5: 3000 pg/mL | Check 1: ≤0.15 ng/mLCheck 2: 2.0 ng/mLCheck 3: 30.0 ng/mLCheck 4: 45.0 ng/mLCheck 5: 60.0 ng/mL |
| Format | Lyophilized | Lyophilized |
| Handling | Reconstitute Check 1, Check 2,Check 3, Check 4, and Check 5with exactly 1.0mL distilled ordeionized water. Allow to standclosed for 15 minutes, then mixgently by inversion to ensurehomogeneity. | Reconstitute Check 1, Check 2, Check 3,Check 4, and Check 5 with exactly1.0mL distilled or deionized water.Allow to stand closed for 15 minutes,then mix gently by inversion to ensurehomogeneity. |
| Stability | Unopened:Store at 2-8°C untilexpiration dateOpened:20-25°C: 4 hours | Unopened:Store at 2-8°C until expirationdateOpened:20-25°C: 4 hours |
| Traceability | The Elecsys Progesterone III CalCheck 5 was standardized against ID-GC/MS(isotope dilution gas chromatography mass spectrometry). | |
| ValueAssignment | Value assignment testing was conducted and passed pre-defined acceptancecriteria. For each Elecsys Progesterone III CalCheck 5 lot manufactured, theCalChecks are run in duplicate on at least three cobas e 601 analyzers. The assignedvalue of each CalCheck is defined as the mean value obtained over at least 6determinations (duplicate runs on at least 3 analyzers) of the respective CalCheck. | |
| The CalCheck assigned range is calculated as ±27% of the assigned valuefor levels 2 through 5. The label states that each laboratory should establishappropriate acceptance criteria when using this product for its intended use. | ||
| The same value assignment procedure is performed on the cobas e 411 . Theassigned values obtained are compared to those obtained on the cobas e 601 . Themean value obtained on the additional analyzer must be within 10% of the masterplatform assigned value. After this acceptance criterion is met, the assigned valuesfrom the master platform are deemed valid for the MODULAR ANALYTICS E170,cobas e 411 , cobas e 601 , and cobas e 602 immunoassay analyzers. | ||
| Target Values | The CalCheck target values for the Elecsys Progesterone III Calcheck 5 are asfollows: | |
| Check Target Values | Check 1: ≤ 0.15 ng/mL | |
| Check 2: 2.0 ng/mL | ||
| Check 3: 30.0 ng/mL | ||
| Check 4: 45.0 ng/mL | ||
| Check 5: 60.0 ng/mL | ||
| Continued on next page |
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Comparison of Elecsys Progesterone III CalCheck 5 with the predicate device, Elecsys Estradiol III CalCheck 5 (K142147). Table 1
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Stability Studies
Two studies were performed in order to verify the stability claims for the Progesterone III CalCheck 5. Additionally, a real-time stability study is ongoing to support the shelf-life stability claim.
Opened-vial and accelerated stability studies were completed on the cobas e 411. Because these studies are not analyzer-dependent, these results, in addition to realtime stability study results, can be applied to the MODULAR ANALYTICS E170, cobas e 601 and cobas e 602.
Study 1. Open-Vial Stability:
The on-test and reference materials were tested in duplicate. The on-test material was reconstituted and stored for 5 hours at 25℃ (in an open vial). The reference material was a freshly reconstituted set of CalChecks. The on-test recovery was calculated as a percent of the reference value.
One Progesterone III CalCheck 5 lot was evaluated in duplicate on the cobas e 411. The acceptance criterion for CalCheck Level 1 was < 0.15 ng/mL. for CalCheck Level 2 85-115% and for level 3-5 90-110% recovery of the reference material value. The data support the package insert claim that reconstituted Progesterone III CalCheck 5 is stable up to 4 hours at 20-25°C.
The CalCheck products are not stored on-board the analyzer, therefore no on-board stability claims are made.
Study 2. Accelerated Stability:
The on-test material was stored lyophilized (as supplied to the user) at 35℃ for 3 weeks. The reference material was a freshly reconstituted set of CalChecks (stored at 2-8℃). After 3 weeks, the test and reference materials were tested in duplicate. The on-test recovery was calculated as a percent of the reference value.
One Progesterone III CalCheck 5 lot was evaluated in duplicate on the cobas e 411. The acceptance criterion for CalCheck Level 1 was ≤ 0.15 ng/mL, for CalCheck Level 2 85-115% and for level 3-5 90-110% recovery of the reference material value.
The accelerated stability model employed supports an initial shelf-life claim of 18 months when the Progesterone III CalCheck 5 are stored under normal storage conditions of 2-8°C.
We trust that the information provided in this Premarket Notification (510(k)) will Conclusion support a determination of substantial equivalence for the Elecsys Progesterone III Calcheck 5.
§ 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.