(28 days)
No
The summary describes a calibration set for an immunoassay, which is a chemical reagent used to calibrate a laboratory instrument. There is no mention of AI or ML in the intended use, device description, or any other section.
No
Explanation: This device is explicitly described as a calibrator for an assay, not for treating any medical condition.
No
Explanation: The device is a calibrator for an assay, not a diagnostic device itself. Its purpose is to ensure the accuracy of a diagnostic assay rather than to diagnose a condition.
No
The device description explicitly states it consists of physical components (equine serum matrix, human serum matrix, human TSH) in a liquid format, indicating it is a physical reagent kit, not software.
Based on the provided information, the Elecsys TSH CalSet is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's used for "calibrating the quantitative Elecsys TSH assay". Calibration materials are essential components of IVD assays, ensuring the accuracy and reliability of the test results obtained from patient samples.
- Device Description: The description mentions it consists of serum matrices and human TSH, which are typical components of calibrators used in immunoassay testing of biological samples (serum).
- Predicate Device: The mention of a predicate device (K961491; Elecsys TSH CalSet) strongly indicates that this device is regulated as an IVD, as predicate devices are used for comparison in regulatory submissions for new IVDs.
While the document doesn't explicitly state "In Vitro Diagnostic Device" in the intended use, the function of calibrating an immunoassay for TSH (a substance measured in biological samples) firmly places it within the definition of an IVD.
N/A
Intended Use / Indications for Use
The Elecsys TSH CalSet is used for calibrating the quantitative Elecsys TSH assay on the Elecsys immunoassay analyzers.
Product codes
JIT
Device Description
The Elecsys TSH CalSet consists of equine serum matrix (Cal 1) and a human serum matrix with human TSH (Cal 2) in two concentration ranges. The Elecsys TSH CalSet is supplied in ready for use liquid format.
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)
Not Found
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
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
APE 1 8 2006
510(k) Summary - Elecsys TSH CalSet
| 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 Rd | |
| Indianapolis IN 46250 | |
| (317) 521-3544 | |
| Contact person: Kay A. Taylor | |
| Date prepared: March 17, 2006 | |
| Device Name | Proprietary name: Elecsys TSH CalSet |
| Common name: Calibrator | |
| Classification name: Calibrator, Secondary | |
| Device description | The Elecsys TSH CalSet consists of equine serum matrix (Cal 1) and a human serum matrix with human TSH (Cal 2) in two concentration ranges. The Elecsys TSH CalSet is supplied in ready for use liquid format. |
1
510(k) Summary - Elecsys® TSH CalSet, continued
| Intended use | Elecsys TSH CalSet is used for calibrating the quantitative Elecsys TSH
assay on the Elecsys immunoassay analyzers. | |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Predicate
Device | The Elecsys TSH CalSet is equivalent to other devices legally marketed in the
United States. We claim equivalence to the Elecsys TSH CalSet (K961491). | |
| Device
Comparison | The table below compares the device features of the Elecsys TSH CalSet
(modified) and original (K961491). | |
| Topic | Elecsys TSH CalSet
(K961491) | Elecsys TSH CalSet
(Modified Device) |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Used for calibrating the quantitative
Elecsys TSH assay on the Elecsys
2010 immunoassay analyzer. | Used for calibrating the quantitative
Elecsys TSH assay on the Elecsys
immunoassay analyzers. |
| Traceability | Assay standardized against the 2nd IRP
WHO reference standard 80/558 | Same |
| Levels | Two | Same |
| Storage Form | Liquid | Same |
| Matrix | Horse serum matrix with added
recombinant TSH | Equine serum matrix with added TSH
(human). |
| Stability | Unopened:
ο at 2-8°C up to the stated
expiration date.
Opened:
ο 4 weeks at at 2-8°C
ο on the analyzer up to a maximum
of five hours in total. | Unopened:
ο at 2-8°C up to the stated
expiration date.
Opened:
ο after opening in aliquots at 2-8°C
for 12 weeks.
ο on 1010/2010 at 20-25°C up to 5
hours
ο on E170 use only once. |
| Target
Concentrations | Cal 1: 0 µIU/mL
Cal 2: 1.5 µIU/mL | Same |
:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular logo with a stylized bird in the center. The bird has a long, curved neck and three wing-like shapes extending from its body. The bird is black, and the background is white. The text around the circle is not legible.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 1 3 2006
Ms. Kay A. Taylor Regulatory Affairs Principal Roche Diagnostics Corp. 9115 Haguc Road Indianapolis, IN 46250
Re: K060754 Trade/Device Name: Elecsys TSH CalSet Regulation Number: 21 CFR8862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: March 17, 2006 Received: March 21, 2006
Dear Ms. Taylor:
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 your 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 C FR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Albert Gutt
Alberto Gutierrez, 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
Indications for Use
510(k) Number (if known): K060754
Device Name: Elecsys TSH CalSet
Indications For Use:
The Elecsys TSH CalSet is used for calibrating the quantitative Elecsys TSH assay on the Elecsys immunoassay analyzers.
Prescription Use XXXX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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