(32 days)
The Elecsys Estradiol 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 Estradiol III reagent on the indicated Elecsys and cobas e immunoassay analyzers.
The Elecsys Estradiol III CalCheck 5 is a lyophilized product consisting of 5 different levels of synthetic Estradiol in a human serum matrix. It has been standardized against ID-GC/MS (isotope dilution gas chromatography mass spectrometry).
This document is a 510(k) summary for the Elecsys Estradiol III CalCheck 5, a control material used for calibrating and verifying the assay range of the Elecsys Estradiol III reagent on Roche immunoassay analyzers. It outlines the device description, intended use, and substantial equivalence to a predicate device. The document details studies performed to establish stability claims.
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1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily related to recovery rates and target values for the different CalCheck levels, as well as the comparison of assigned values across different analyzer platforms.
| Acceptance Criterion | Reported Device Performance | Study |
|---|---|---|
| Value Assignment:For each CalCheck 5 lot, the assigned value is the mean over at least 6 determinations (duplicate runs on at least 3 analyzers). | Value assignment testing was conducted and passed pre-defined acceptance criteria. Assigned values are those obtained from the master platform (cobas e 601). | Value Assignment Procedure |
| Value Assignment:CalCheck assigned range is ±27% of the assigned value for levels 2 through 5. | This is a calculated range, not a performance metric to be passed in a study in the same way as recovery. The document states laboratories should establish their own acceptance criteria within this range. | Value Assignment Procedure |
| Value Assignment (Cross-platform comparability):Mean value obtained on additional analyzers (e.g., cobas e 411/Elecsys 2010) must be within 10% of the master platform (cobas e 601) assigned value. | The acceptance criterion was met, indicating consistency across analyzer platforms. | Value Assignment Procedure |
| Open-Vial Stability (CalCheck Level 1):≤ 10 pg/mL | Not explicitly stated if the on-test recovery for level 1 was ≤ 10 pg/mL, but the conclusion states "The data support the package insert claim that reconstituted Estradiol III CalCheck 5 is stable up to 4 hours at 20-25°C." This implies the criterion was met. | Open-Vial Stability Study |
| Open-Vial Stability (CalCheck Level 2):85-115% recovery of the reference material value | The data supports the package insert claim, implying this criterion was met. | Open-Vial Stability Study |
| Open-Vial Stability (CalCheck Levels 3-5):90-110% recovery of the reference material value | The data supports the package insert claim, implying this criterion was met. | Open-Vial Stability Study |
| Accelerated Stability (CalCheck Level 1):≤ 10 pg/mL | Not explicitly stated if the on-test recovery for level 1 was ≤ 10 pg/mL, but the conclusion states "The accelerated stability model employed supports an initial shelf-life claim of 18 months..." This implies the criterion was met. | Accelerated Stability Study |
| Accelerated Stability (CalCheck Level 2):85-115% recovery of the reference material value | The accelerated stability model supports the shelf-life claim, implying this criterion was met. | Accelerated Stability Study |
| Accelerated Stability (CalCheck Levels 3-5):90-110% recovery of the reference material value | The accelerated stability model supports the shelf-life claim, implying this criterion was met. | Accelerated Stability Study |
2. Sample Size Used for the Test Set and Data Provenance
- Open-Vial Stability Study: One Elecsys Estradiol III CalCheck 5 lot was evaluated. Each condition (on-test and reference) was tested in duplicate.
- Accelerated Stability Study: One Elecsys Estradiol III CalCheck 5 lot was evaluated. Each condition (on-test and reference) was tested in duplicate.
- Value Assignment Procedure: For each lot, the CalChecks are run in duplicate on at least three cobas e 601/MODULAR ANALYTICS E170 analyzers (total of at least 6 determinations). For cross-platform comparison, mean values are also obtained on other specified analyzers.
Data Provenance: The document does not explicitly state the country of origin of the data, but the submitter is Roche Diagnostics, an international company. The studies appear to be laboratory-based verification/validation studies, not clinical studies. The data is likely prospective within the context of these specific laboratory tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as this device is a quality control material and the studies are laboratory-based stability and value assignment tests, not studies involving expert interpretation of patient data. The "ground truth" for the CalChecks are the defined target values and precise measurements, not expert consensus.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. There is no concept of adjudication by human experts in these types of laboratory studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation or decision-making. The Elecsys Estradiol III CalCheck 5 is a quality control material for an immunoassay, and its performance is assessed through analytical accuracy and stability, not human interpretation.
6. Standalone (Algorithm Only) Performance
This is not applicable in the traditional sense of a standalone algorithm for medical image analysis or complex diagnostic interpretation. This device is a control material used to verify the performance of an immunoassay analyzer. The "performance" being evaluated is the chemical and analytical stability and assigned values of the control material itself, and its interaction with the immunoassay system. The system (immunoassay analyzer) operates in a standalone fashion in terms of detecting the analyte, and the control material helps verify its proper functioning.
7. Type of Ground Truth Used
The ground truth used for this device is based on analytical measurements and standardization against a highly accurate reference method:
- Assigned Values/Target Values: Defined by the manufacturer through rigorous laboratory testing. For Estradiol, the device was standardized against ID-GC/MS (isotope dilution gas chromatography mass spectrometry), which is considered a highly accurate and precise reference method.
- Reference Material values: For stability studies, "reference material" refers to freshly reconstituted CalChecks stored under optimal conditions, which serve as the baseline for comparison.
8. Sample Size for the Training Set
This information is not applicable. This device is a quality control material; it is not based on a machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 5, 2014
ROCHE DIAGNOSTICS KELLI TÜRNER REGULATORY AFFAIRS PRINCIPAL 9115 HAGUE ROAD, P. O. BOX 50416 INDIANAPOLIS IN 46250-0416
Re: K142127
Trade/Device Name: Elecsys Estradiol 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: August 1, 2014 Received: August 4, 2014
Dear Ms. Turner:
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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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.
Courtney
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) K142127
Device Name Elecsys Estradiol III CalCheck 5
Indications for Use (Describe)
The Elecsys Estradiol III CalCheck 5 is an assayed control for use in calibration and for use in the verification of the assay range established by the Elecsys Estradiol 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, Elecsys Estradiol III CalCheck 5
| 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. | ||
|---|---|---|---|
| 510(k) Number | K142127. | ||
| Submitter name, address, contact | Roche Diagnostics9115 Hague Road, P.O. Box 50416Indianapolis, IN 46250-0416 | ||
| Contact Person: Kelli TurnerPhone: 317-521-4515Fax: 317-521-2324Email: kelli.turner@roche.com | |||
| Secondary Contact: Michael LeutherPhone: 317-521-3930Fax: 317-521-2324Email: michael.leuther@roche.com | |||
| Date Prepared: September 4, 2014 | |||
| Device Name | Proprietary name: | Elecsys Estradiol III CalCheck 5 | |
| Common name: | Estradiol III CalCheck 5 | ||
| Classification: | 21 CFR 862.1660, Single (specified) analyte controls (assayed and unassayed) | ||
| Product Code: | JJX Single (Specified) Analyte Controls | ||
| Panel: | Clinical Chemistry (75) |
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| DeviceDescription | Elecsys Estradiol III CalCheck 5:The Elecsys Estradiol III CalCheck 5 is a lyophilized product consisting of 5 different levels of synthetic Estradiol in a human serum matrix. It has been standardized against ID-GC/MS (isotope dilution gas chromatography mass spectrometry). |
|---|---|
| Intended use | Elecsys Estradiol III CalCheck 5:The Elecsys Estradiol 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 Estradiol III reagent on the indicated Elecsys and cobas e immunoassay analyzers. |
| Predicatedevice | The Elecsys Estradiol III CalCheck 5 is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys CK-MB CalCheck 5 (K133284).Continued on next page |
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Comparison The table below compares Elecsys Estradiol III CalCheck 5 with the predicate Table device, Elecsys CK-MB CalCheck 5 (K133284).
| Characteristic | Elecsys Estradiol IIICalCheck 5(Candidate) | Elecsys CK-MB CalCheck 5(K133284) |
|---|---|---|
| Intended Use | The Elecsys Estradiol IIICalCheck 5 is an assayedcontrol for use in calibrationverification and for use in theverification of the assay rangeestablished by the ElecsysEstradiol III reagent on theindicated Elecsys and cobas eimmunoassay analyzers. | The Elecsys CK-MB CalCheck5 is an assayed control for use incalibration verification and foruse in the verification of theassay range established by theElecsys CK-MB reagent on theindicated Elecsys and cobas eimmunoassay analyzers. |
| Analyte | Estradiol (synthetic) | Human CK-MB |
| Matrix | Human serum matrix | Same |
| Levels | Five | Same |
| AssayMeasuringRange | 5 – 3000 pg/mL | 1 – 300 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: ≤ 1.00 ng/mLCheck 2: 5.0 ng/mLCheck 3: 150 ng/mLCheck 4: 240 ng/mLCheck 5: 300 ng/mL |
| Format | Lyophilized | Same |
| Handling | Reconstitute Check 1, Check 2,Check 3, Check 4, and Check 5with exactly 1.0 mL distilled ordeionized water. Allow to standclosed for 15 minutes, then mixgently by inversion to ensurehomogeneity. | Same |
| Stability | Unopened:• Store at 2-8°C until expirationdateOpened:• 20-25°C: 4 hours | Same |
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Traceability The Elecsys Estradiol III CalCheck 5 was standardized against ID-GC/MS (isotope dilution gas chromatography mass spectrometry).
Value Value assignment testing was conducted and passed pre-defined Assignment acceptance criteria. For each Elecsys Estradiol III CalCheck 5 lot manufactured, the CalChecks are run in duplicate on at least three cobas e 601/MODULAR ANALYTICS E170 analyzers. The assigned value of each CalCheck is defined as the mean value obtained over at least 6 determinations (duplicate runs on at least 3 analyzers) of the respective CalCheck.
The CalCheck assigned range is calculated as ±27% of the assigned value for levels 2 through 5. The label states that each laboratory should establish appropriate acceptance criteria when using this product for its intended use.
The same value assignment procedure is performed on the cobas e 411/Elecsys 2010. The assigned values obtained are compared to those obtained on the cobas e 601/MODULAR ANALYTICS E170. The mean value obtained on the additional analyzer must be within 10% of the master platform (cobas e 601) assigned value. After this acceptance criterion is met, the assigned values from the master platform are deemed valid for the MODULAR ANALYTICS E170, Elecsys 2010, cobas e 411, cobas e 601, and cobas e 602 immunoassay analyzers.
Target Values
The CalCheck target values for the Elecsys Estradiol III are as follows:
| Check Target Values | Check 1: $\u2264$ 10 pg/mL |
|---|---|
| Check 2: 100 pg/mL | |
| Check 3: 1500 pg/mL | |
| Check 4: 2400 pg/mL | |
| Check 5: 3000 pg/mL |
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Two studies were performed in order to verify the stability claims for the Stability Estradiol III CalCheck 5. Additionally, a real-time stability study is planned. Studies
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 real-time stability study results, can be applied to the Elecsys 2010, 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 6 hours at 25℃ (in an open vial). The reference material was a freshly reconstituted set of CalChecks. The ontest recovery was calculated as a percent of the reference value.
One Estradiol III CalCheck 5 lot was evaluated in duplicate on the cobas e 411. The acceptance criterion for CalCheck Level 1 is ≤ 10 pg/mL; for CalCheck Level 2 the acceptance criterion is 85-115% recovery; and for CalCheck Levels 3-5, the acceptance criterion is recovery of 90-110% recovery of the reference material value.
The data support the package insert claim that reconstituted Estradiol III CalCheck 5 is stable up to 4 hours at 20-25°C.
The CalCheck products are not stored on-board the analyzers, 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°C 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 Estradiol III CalCheck 5 lot was evaluated in duplicate on the cobas e 411. The acceptance criterion for CalCheck Level 1 is ≤ 10 pg/mL; for CalCheck Level 2 the acceptance criterion is 85-115% recovery; and for CalCheck Levels 3-5, the acceptance criterion is recovery of 90-110% of the reference material value.
The accelerated stability model employed supports an initial shelf-life claim of 18 months when the Estradiol III CalCheck 5 are stored under normal storage conditions of 2-8°C.
Conclusion We trust that the data and information provided in this Premarket Notification 510(k) submission will support a determination of substantial equivalence for the Elecsys Estradiol 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.