(48 days)
Not Found
No
The document describes a calibration control product for an immunoassay analyzer, which is a standard laboratory reagent and does not mention any AI/ML components or functionalities.
No
The device is described as an assayed control for calibration verification and for verifying the assay range of a reagent used on immunoassay analyzers, not for treating a disease or condition.
No
This device is an assayed control used for calibration verification and to verify the assay range for a diagnostic test. It is not a diagnostic device itself, but rather a tool to ensure the accuracy of a diagnostic test.
No
The device description clearly states it is a "lyophilized product consisting of T4 in 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 clearly states it's for "calibration verification and for use in the verification of the assay range established by the Elecsys T4 reagent on the indicated Elecsys and cobas e immunoassay analyzers." This describes a product used in vitro (outside the body) to assess the performance of a diagnostic test (the Elecsys T4 reagent).
- Device Description: It's a "lyophilized product consisting of T4 in human serum matrix." This is a biological material designed to be used in a laboratory setting with an immunoassay analyzer.
- Predicate Device: The predicate device listed, "Elecsys T3 CalCheck 5," is also a control product for an immunoassay, further supporting the IVD nature of this device.
The core function of this device is to ensure the accuracy and reliability of an in vitro diagnostic test (the Elecsys T4 assay). This aligns directly with the definition of an IVD.
N/A
Intended Use / Indications for Use
The Elecsys T4 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 T4 reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
The Elecsys T4 CalCheck 5 is a lyophilized product consisting of T4 in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Elecsys T4 CalCheck 5 was evaluated for value assignment and stability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K11a528
OCT 1 8 2011
| 510(k) Summary | OCT 1 8 2011 |
|---|---|
| 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 | |
| 317-521-3577 | |
| Contact Person: Michael Leuther, Ph.D. | |
| Phone: 317-521-3930 | |
| Fax: 317-521-2324 | |
| Email: michael.leuther@roche.com | |
| Secondary Contact: Stephanie Greeman | |
| Phone: 317-521-2458 | |
| Fax: 317-521-2324 | |
| Email: stephanie.greeman@roche.com | |
| Date Prepared: August 29, 2011 | |
| Device Name | Proprietary name: Elecsys T4 CalCheck 5 |
| Common name: T4 CalCheck 5 | |
| Classification name: Single (specified) analyte controls (assayed and | |
| unassayed) | |
| Predicate | |
| device | The Elecsys T4 CalCheck 5 is substantially equivalent to other products in |
| commercial distribution intended for similar use. We claim equivalency to the | |
| currently marketed Elecsys T3 CalCheck 5 (K111552). | |
| Device | |
| Description | The Elecsys T4 CalCheck 5 is a lyophilized product consisting of T4 in |
| human serum matrix. During manufacture, the analyte is spiked into the | |
| matrix at the desired concentration levels. | |
| Intended use | The Elecsys T4 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 T4 reagent on the indicated Elecsys and cobas e immunoassay | |
| analyzers, for in vitro diagnostic use only. |
Continued on next page
1
510(k) Summary, Continued
The table below compares Elecsys T4 CalCheck 5 with the predicate device, Comparison Table Elecsys T3 CalCheck 5 (K111552). The predicate shows that T4 CalCheck 5 is substantially equivalent to T3 CalCheck 5, with several key similarities. The shaded fields indicate similar characteristics between the candidate
device and the predicate device.
| Characteristic | Elecsys T3 CalCheck 5
(Predicate Device, K111552) | Elecsys T4 CalCheck 5
(Candidate Device) |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Elecsys T3 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 T3 quantitative assay reagent on the indicated Elecsys and cobas e immunoassay analyzers. | The Elecsys T4 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 T4 reagent on the indicated Elecsys and cobas e immunoassay analyzers. |
| Analyte | Triiodothyronine (T3) | Thyroxine (T4) |
| Levels | Five | Five |
| Assay Measuring Range | 0.300 - 10.0 nmol/L | 5.40 - 320 nmol/L |
| Check Target Values | Check 1: ≤ 0.2 nmol/L
Check 2: 2.0 nmol/L
Check 3: 5 nmol/L
Check 4: 8 nmol/L
Check 5: 10 nmol/L | Check 1: K112528 Trade Name: Elecsys T4 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: August 30, 2011 Received: August 31, 2011
Dear Dr. Leuther:
Re:
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 vour 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 Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric' s (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm.
Sincerely yours,
signature
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indication for Use
510(k) Number (if known): Kll 2528
Device Name: Elecsys T4 CalCheck 5
Indication For Use:
The Elecsys T4 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 T4 reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Prescription Use __ X (21 CFR Part 801 Subpart D)
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Qus
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K112528
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