(32 days)
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No
The summary describes a calibration control for an immunoassay analyzer and does not mention any AI or ML components.
No
The device is an assayed control for calibration verification and verification of assay range; it is not used to treat, prevent, or diagnose disease.
No
The device is described as 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." This indicates it is used to verify the performance of other diagnostic devices, not to diagnose a patient's condition directly.
No
The device description explicitly states it is a "lyophilized product consisting of 5 different levels of synthetic Estradiol in a human serum matrix," indicating it is a physical reagent, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "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." This clearly indicates its use in a laboratory setting to ensure the accuracy and performance of an in vitro diagnostic test (the Elecsys Estradiol III reagent).
- Device Description: It's a "lyophilized product consisting of 5 different levels of synthetic Estradiol in a human serum matrix." This describes a control material used in laboratory testing.
- Performance Studies: The studies described (Open-Vial Stability and Accelerated Stability) are typical performance evaluations for IVD control materials.
- Predicate Device: The mention of a predicate device (K133284; Elecsys CK-MB CalCheck 5) which is also a CalCheck product, further supports its classification as an IVD.
While the document doesn't explicitly state "In Vitro Diagnostic," the context of its intended use, description, and performance studies strongly align with the definition of an IVD device, specifically a control material used in conjunction with an IVD assay.
N/A
Intended Use / Indications for Use
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.
Product codes
JJX
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Two studies were performed in order to verify the stability claims for the Estradiol III CalCheck 5. Additionally, a real-time stability study is planned.
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°C (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 Estradiol III CalCheck 5 lot was evaluated in duplicate on the cobas e 411.
The data support the package insert claim that reconstituted Estradiol III CalCheck 5 is stable up to 4 hours at 20-25°C.
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°C). 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 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.
Key Metrics
Study 1. Open-Vial Stability:
Acceptance criterion for CalCheck Level 1 is less than or equal to 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.
Study 2. Accelerated Stability:
Acceptance criterion for CalCheck Level 1 is less than or equal to 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.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three faces in profile, one behind the other.
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.
1
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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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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 Diagnostics | ||
| 9115 Hague Road, P.O. Box 50416 | |||
| Indianapolis, IN 46250-0416 | |||
| Contact Person: Kelli Turner | |||
| Phone: 317-521-4515 | |||
| Fax: 317-521-2324 | |||
| Email: kelli.turner@roche.com | |||
| Secondary Contact: Michael Leuther | |||
| Phone: 317-521-3930 | |||
| Fax: 317-521-2324 | |||
| Email: 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) |
Continued on next page
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| Device
Description | 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. |
| Predicate
device | 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 III
CalCheck 5
(Candidate) | Elecsys CK-MB CalCheck 5
(K133284) |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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 CK-MB 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 CK-MB reagent on the
indicated Elecsys and cobas e
immunoassay analyzers. |
| Analyte | Estradiol (synthetic) | Human CK-MB |
| Matrix | Human serum matrix | Same |
| Levels | Five | Same |
| Assay
Measuring
Range | 5 – 3000 pg/mL | 1 – 300 ng/mL |
| Check Target
Values | Check 1: ≤ 10 pg/mL
Check 2: 100 pg/mL
Check 3: 1500 pg/mL
Check 4: 2400 pg/mL
Check 5: 3000 pg/mL | Check 1: ≤ 1.00 ng/mL
Check 2: 5.0 ng/mL
Check 3: 150 ng/mL
Check 4: 240 ng/mL
Check 5: 300 ng/mL |
| Format | Lyophilized | Same |
| Handling | Reconstitute Check 1, Check 2,
Check 3, Check 4, and Check 5
with exactly 1.0 mL distilled or
deionized water. Allow to stand
closed for 15 minutes, then mix
gently by inversion to ensure
homogeneity. | Same |
| Stability | Unopened:
• Store at 2-8°C until expiration
date
Opened:
• 20-25°C: 4 hours | Same |
Continued on next page
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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 |
Continued on next page
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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.