(28 days)
No
The document describes a control material for an immunoassay analyzer and does not mention any AI or ML components. The performance studies focus on value assignment and stability, not algorithmic performance.
No
This device is an assayed control used for calibration and verification of a diagnostic assay (Elecsys CK-MB reagent), not for treating a condition or disease.
No
This device is described as an "assayed control for use in calibration and for use in the verification of the assay range" of diagnostic analyzers, not as a diagnostic device itself.
No
The device description clearly states it is a "lyophilized product consisting of human creatine kinase MB isoenzyme (CK-MB) in a human serum matrix," indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "use in calibration and for use in the verification of the assay range established by the Elecsys CK-MB reagent on the indicated Elecsys and cobas e innunoassay analyzers." This indicates it's used in vitro (outside the body) to assess the performance of a diagnostic test (the Elecsys CK-MB reagent).
- Device Description: It's a "lyophilized product consisting of human creatine kinase MB isoenzyme (CK-MB) in a human serum matrix." This is a biological material designed to be used in a laboratory setting for testing.
- Performance Studies: The performance studies describe testing done on analyzers to evaluate the "value assignment and stability" of the product when used with the Elecsys CK-MB reagent. This further confirms its role in the in vitro diagnostic process.
- Predicate Device: The predicate device listed is also an "Elecsys CK-MB CalCheck 5," which is consistent with it being a control material used in IVD testing.
All these factors point to the Elecsys CK-MB CalCheck 5 being a product used in vitro to support the accuracy and reliability of a diagnostic test, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
JJX
Device Description
The Elecsys CK-MB CalCheck 5 is a lyophilized product consisting of human creatine kinase MB isoenzyme (CK-MB) in a human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods applied were FDA-approved or cleared in compliance with the European Directive 98/79/EC, Annex II, List A. However, as no testing method can rule out the potential risk of infection with absolute certainty, the material should be handled with the same level of care as a patient specimen. In the event of exposure, the directives of the responsible health authorities should be followed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Value Assignment: Value assignment testing was conducted and passed pre-defined acceptance criteria. For each Elecsys CK-MB CalCheck 5 lot manufactured, the CalChecks are run in duplicate on at least three Elecsys 2010 analyzers. The assigned value of each CalCheck is defined as the median value obtained over at least 6 determinations (duplicate runs on at least 3 analyzers) of the respective CalCheck. The assigned range is calculated as +/-27% of assigned value for level 2 and as +/-30% of the assigned value for levels 3 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 MODULAR ANALYTICES E170. The assigned values obtained are compared to those obtained on the Elecsys 2010. The median value obtained on the additional analyzer must be within 10% of the master platform 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.
Stability: Real-time and open-vial stability tests were conducted to establish the shelf-life and open-vial claims.
Open-Vial Stability After Reconstitution: Testing was performed and the data support the package insert claim that reconstituted Elecsys CK-MB CalCheck 5 is stable up to 4 hours at 20-25 degrees C.
Shelf-Life Stability: Real-time testing done at 2-8 degrees C supports a claim of 36 months.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
NOV 2 2 2013
| 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, 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: Colleen Adams | |||||||||
| Phone: 317-521-3577 | |||||||||
| Fax: 317-521-2324 | |||||||||
| Email: colleen.adams@roche.com | |||||||||
| Date Prepared: November 22, 2013 | |||||||||
| Device Name | |||||||||
| Proprietary name:Elecsys CK-MB CalCheck 5Common name:CK-MB CalCheck 5Classification:21 CFR 862.1660, Single (specified) analyte controls (assayed and unassayed)Product Code:JJX | Proprietary name: | Elecsys CK-MB CalCheck 5 | Common name: | CK-MB CalCheck 5 | Classification: | 21 CFR 862.1660, Single (specified) analyte controls (assayed and unassayed) | Product Code: | JJX | |
| Proprietary name: | Elecsys CK-MB CalCheck 5 | ||||||||
| Common name: | CK-MB CalCheck 5 | ||||||||
| Classification: | 21 CFR 862.1660, Single (specified) analyte controls (assayed and unassayed) | ||||||||
| Product Code: | JJX | ||||||||
| Device Description | The Elecsys CK-MB CalCheck 5 is a lyophilized product consisting of human creatine kinase MB isoenzyme (CK-MB) in a human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. |
All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods applied were FDA-approved or cleared in compliance with the European Directive 98/79/EC, Annex II, List A. However, as no testing method can rule out the potential risk of infection with absolute certainty, the material should be handled with the same level of care as a patient specimen. In the event of exposure, the directives of the responsible health authorities should be followed. | | | | | | | | |
| | Continued on next page | | | | | | | | |
510(k) Summary
,
i
Continued on next page
1
| | Intended use | 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. | | |
|--|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | Predicate
device | The Elecsys CK-MB 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 (K093582). | | |
| | Performance
Characteristics | The Elecsys CK-MB CalCheck 5 was evaluated for value assignment and
stability. See the following sections for details. | | |
| | Traceability | The Elecsys CK-MB CalCheck 5 was standardized against the Elecsys CK-
MB STAT assay, which is traceable to the Abbott IMx assay and linearized
using human recombinant CK-MB from Seradyn. | | |
2
510(k) Summary, Continued
The following table compares the CK-MB CalCheck 5 with the predicate Substantial device, Elecsys CK-MB CalCheck 5 (K093582). Equivalence Comparison
| Characteristic | Elecsys CK-MB CalCheck 5
(Candidate) | Elecsys CK-MB CalCheck 5
(K093582) |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Intended Use | 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. | Same |
| Analyte | Human CK-MB | Same |
| Matrix | Human serum matrix | Same |
| Levels | Five | Same |
| 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
3
510(k) Summary, Continued
·
| Value Assignment | Value assignment testing was conducted and passed pre-defined acceptance criteria. For each Elecsys CK-MB CalCheck 5 lot manufactured, the CalChecks are run in duplicate on at least three Elecsys 2010 analyzers. The assigned value of each CalCheck is defined as the median value obtained over at least 6 determinations (duplicate runs on at least 3 analyzers) of the respective CalCheck. The assigned range is calculated as ±27% of assigned value for level 2 and as ±30% of the assigned value for levels 3 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 MODULAR ANALYTICES E170. The assigned values obtained are compared to those obtained on the Elecsys 2010. The median value obtained on the additional analyzer must be within 10% of the master platform 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. | |
| Stability | Real-time and open-vial stability tests were conducted to establish the shelf-life and open-vial claims. |
| Open-Vial Stability After Reconstitution: | |
| Testing was performed and the data support the package insert claim that reconstituted Elecsys CK-MB CalCheck 5 is stable up to 4 hours at 20-25°C. | |
| Shelf-Life Stability: | |
| Real-time testing done at 2-8°C supports a claim of 36 months. |
.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
November 22, 2013
ROCHE DIAGNOSTICS KELLI TÜRNER REGULATORY AFFAIRS PRINCIPAL 9115 HAGUE ROAD, P.O. BOX 50416 INDIANAPOLIS IN 46250-0416
Re: K133284
Trade/Device Name: Elecsys CK-MB CalCheck 5 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: I, reserved Product Code: JJX Dated: October 24, 2013 Received: October 25, 2013
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. Iisting 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.
5
Page 2-Ms. Turner
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Carol C. Benson -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
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133284
Device Name
Elecsys CK-MB CalCheck 5
Indications for Use (Describe)
The Elecsys CK-MB CalCheck 5 is an assayed control for use in calibration and for use in the verification of the assay range established by the Elecsys CK-MB reagent on the indicated Elecsys and cobas e innunoassay analyzers.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
[ ] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.