(121 days)
No
The summary describes a lyophilized control product for immunoassay analyzers, with no mention of AI or ML technology in its function or development.
No
The device is described as an "assayed control for use in calibration verification," indicating it is used to verify the performance of other diagnostic tests (reagents/analyzers), rather than directly treating a disease or condition.
No
Justification: The device description states its use is for "calibration verification and for use in the verification of the assay range established by the Elecsys TSH reagent." This indicates it's used to verify other diagnostic devices, not to diagnose conditions itself. It's a control product, not a diagnostic one.
No
The device description clearly states it is a "lyophilized product consisting of TSH in equine serum matrix," indicating it is a physical substance, not software.
Based on the provided information, the Elecsys TSH CalCheck 5 is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "calibration verification" and "verification of the assay range established by the Elecsys TSH reagent on the indicated Elecsys cobas e immunoassay analyzers." This indicates it's used in vitro (outside the body) to assess the performance of another IVD device (the Elecsys TSH reagent and analyzer).
- Device Description: It's a "lyophilized product consisting of TSH in equine serum matrix." This is a biological material designed to be used in a laboratory setting for testing.
- Predicate Device: The mention of a predicate device (K963147; Elecsys CalCheck TSH) strongly suggests it's a regulated medical device, and given its function, it falls under the IVD category.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment. While the CalCheck 5 itself doesn't directly diagnose a patient, it's an essential component in ensuring the accuracy and reliability of the Elecsys TSH assay, which is used for diagnostic purposes. Therefore, it is considered an IVD accessory or control.
N/A
Intended Use / Indications for Use
The Elecsys TSH 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 TSH reagent on the indicated Elecsys cobas e immunoassay analyzers.
Product codes
JJX
Device Description
The Elecsys TSH CalCheck 5 is a lyophilized product consisting of TSH in equine 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
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Elecsys TSH CalCheck 5 was evaluated for value assignment and stability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
"
APR 1 6 _ J10
510(k) Summary 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 Roche Diagnostics name, address, 9115 Hague Road, P.O. Box 50416 contact Indianapolis, IN 46250-0416 317-521-3577 Contact Person: Kelly Colleen O'Maine Adams Phone: 317-521-3577 Fax: 317-521-2324 Email: colleen.adams@roche.com Secondary Contact: Stephanie Greeman Phone: 317-521-2458 Fax: 317-521-2324 Email: stephanie.greeman@roche.com Date Prepared: March 17, 2010 Device Name Proprietary name: Elecsys TSH CalCheck 5 Common name: TSH CalCheck 5 Classification name: Single (specified) analyte controls (assayed and unassayed) Predicate The Elecsys TSH CalCheck 5 is substantially equivalent to other products in device commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys CalCheck TSH (K963147). Device The Elecsys TSH CalCheck 5 is a lyophilized product consisting of Description TSH in equine serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. Intended use The Elecsys TSH 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 TSH reagent on the indicated Elecsys cobas e immunoassay analyzers.
Continued on next page
Page 1 of 2
1
510(k) Summary, Continued
| Comparison
Table | The table below compares Elecsys TSH CalCheck 5 with the predicate
device, Elecsys CalCheck TSH (K963147). | |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Elecsys CalCheck TSH
(K963147) | Elecsys TSH CalCheck 5 |
| Intended Use | For use in the verification of the
calibration established by the
Elecsys TSH reagent on the
indicated Elecsys and cobas e
immunoassay analyzers. | The Elecsys TSH 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 TSH
reagent on the indicated Elecsys
cobas e immunoassay analyzers. |
| Levels | Three | Five |
| Format | Lyophilized | Same |
| Handling | Reconstitute the contents of Check
1, Check 2 and Check 3 with
exactly 1.0 mL distilled or
deionized water. Allow the bottle to
stand closed for 15 minutes. Mix
gently by inversion to ensure
homogeneity. | 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. |
| Stability | Unopened:
• Store at 2-8°C until expiration
date
Reconstituted:
• 20 - 25°C : 4 hrs | Same |
| Matrix | Equine serum matrix | Same |
Performance
Characteristics
The Elecsys TSH CalCheck 5 was evaluated for value assignment and stability.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, in blue. The caduceus is surrounded by a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The logo is simple and clean, with a focus on the department's name and the national affiliation.
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
APR 3 0 2010
Roche Diagnostics Roche Professional Diagnostics c/o Ms. Kelly Colleen O'Maine Adams Regulatory Affairs Consultant 9115 Hague Road, PO Box 50416 Indianapolis, IN 46250-0416
Re: K093836 Trade Name: Elecsys TSH 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: February 08, 2010 Received: February 12, 2010
Dear Ms. O'Maine Adams:
This letter corrects our substantially equivalent letter of April 15, 2010.
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 (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 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 Part 801); 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.
3
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 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 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Signature
Courtney C. Harper, 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):
Device Name: Elecsys TSH CalCheck 5
Indication For Use:
The Elecsys TSH 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 TSH reagent an the indicated Elecsys and cobas e immunoassay analyzers.
Prescription Use X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part.801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K093836
Page I of I