(107 days)
No
The summary describes a calibration set for an immunoassay, which is a chemical reagent used to standardize the measurement of an analyte. There is no mention of any computational or algorithmic processing that would suggest the use of AI or ML. The performance studies focus on the chemical properties and stability of the calibration set.
No
This device is a calibrator used for an immunoassay, not a device that treats or prevents a disease.
No
Explanation: This device is a CalSet, which is used for calibrating an assay, not for directly diagnosing a condition. It is a component used in a diagnostic process but not a diagnostic device itself.
No
The device description explicitly states it is a "lyophilized product consisting of sheep anti-TPO antibodies in a human serum matrix," indicating it is a physical reagent, not software.
Based on the provided information, the Elecsys Anti-TPO CalSet is not an IVD itself, but it is an accessory used with an IVD.
Here's why:
- Intended Use: The intended use clearly states it is "used for calibrating the quantitative Elecsys Anti-TPO assay". Calibration materials are used to ensure the accuracy of an IVD test, but they are not the test itself.
- Device Description: It's a lyophilized product containing antibodies in a human serum matrix. This is consistent with a calibration material, not a diagnostic test that directly measures an analyte in a patient sample.
- Performance Studies: The performance studies focus on the calibration material's characteristics (value assignment, stability, reconstitution) and its equivalence to a predicate calibration material, not on its ability to diagnose a condition in a patient.
- Predicate Device: The predicate device is also a "CalSet", further indicating its role as a calibration material.
Therefore, while the Elecsys Anti-TPO CalSet is essential for the proper functioning of the Elecsys Anti-TPO assay (which is an IVD), the CalSet itself falls under the category of an IVD accessory or calibrator.
N/A
Intended Use / Indications for Use
Elecsys Anti-TPO CalSet is used for calibrating the quantitative Elecsys Anti-TPO assay on the Elecsys and cobas e immunoassay analyzers.
Product codes
JIX
Device Description
The Elecsys® Anti-TPO CalSet is a lyophilized product consisting of sheep anti-TPO antibodies in a 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
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® Anti-TPO CalSet was evaluated for value assignment, stability, and reconstitution.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Elecsys® Anti-TPO CalSet 510(k) Summary ורו30/ 1 FEB 11 1 1 1
| 510(k) Summary | FEB 11 2011 K103171 |
|---|---|
| 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: Sarah Baumann
Phone: 317-521-3952
Fax: 317-521-2324
Email: sarah.baumann@roche.com
Secondary Contact: Stephanie Greeman
Phone: 317-521-2458
Email: stephanie.greeman@roche.com
Date Prepared: October 26, 2010 |
| Device name | Proprietary name: Elecsys® Anti-TPO CalSet
Common name: Anti-TPO CalSet
Classification name: Calibrator, Secondary |
| Predicate
device | The Elecsys® Anti-TPO CalSet is substantially equivalent to other products in
commercial distribution intended for similar use. We claim equivalency to the
currently marketed Elecsys® Anti-TPO CalSet (cleared as part of the Elecsys®
Anti-TPO test system on K051890). |
| Device
description | The Elecsys® Anti-TPO CalSet is a lyophilized product consisting of sheep
anti-TPO antibodies in a human serum matrix. During manufacture, the
analyte is spiked into the matrix at the desired concentration levels. |
| Intended use | Elecsys Anti-TPO CalSet is used for calibrating the quantitative Elecsys
Anti-TPO assay on the Elecsys and cobas e immunoassay analyzers. |
| Reason for
submission | The Elecsys® Anti-TPO CalSet is being changed from a liquid to lyophilized
material. The formulation of the candidate device (Elecsys® Anti-TPO
CalSet, lyophilized) is identical to that of the predicate device, Elecsys®
Anti-TPO CalSet (liquid, and cleared as part of the Elecsys® Anti-TPO test
system on K051890). |
Continued on next page
1
510(k) Summary. Continued
The Elecsys® Anti-TPO CalSet is currently sold to customers as part of the Comparison table Elecsys® Anti-TPO assay kit. Upon clearance of the modified Elecsys® Anti-TPO CalSet device, it will be packaged and sold separately from the Elecsys® Anti-TPO assay kit.
Table 1 below compares Elecsys® Anti-TPO CalSet (K103171) with the predicate device, Elecsys® Anti-TPO CalSet (cleared as part of the Elecsys® Anti-TPO Test System on K051890).
| Characteristic | Elecsys® Anti-TPO CalSet
(Candidate Device, K103171) | Elecsys® Anti-TPO CalSet
(K051890) |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Elecsys Anti-TPO CalSet is used for
calibrating the quantitative Elecsys
Anti-TPO assay on the Elecsys and
cobas e immunoassay analyzers. | The Elecsys Anti-TPO immunoassay is for the in
vitro quantitative determination of antibodies to
thyroid peroxidase in human serum and plasma. The
anti-TPO determination is used as an aid in the
diagnosis of autoimmune thyroid diseases. |
| | | The electrochemiluminescence assay "ECLIA" is
intended for use on the Roche Elecsys 1010/2010
and MODULAR ANALYTICS E170 (Elecsys
module) immunoassay analyzers.1 |
| Material Form
(Format) | Lyophilized | Liquid |
| Analyte | Anti-TPO Antibodies (Sheep) | Same |
| Traceability | NIBSC (National Institute for
Biological Standards and Controls)
66/387 International Standard | Same |
| Matrix | Human serum | Same |
| Levels and
Corresponding
Concentrations | Two
Calibrator 1: approx. 35.0 IU/mL
Calibrator 2: approx. 350 IU/mL | Two
Calibrator 1: approx. 35.0 IU/mL
Calibrator 2: approx. 350 IU/mL |
| Stability | Unopened:
• Store at 2-8°C until expiration date
Reconstituted:
• at 2-8°C: 7 days
• at -20 °C: 8 weeks (freeze only once)
• on the analyzers at 20-25 °C: use
only once | Unopened:
• Store at 2-8°C until expiration date
Opened:
• at 2-8°C: 6 weeks
• at 20-25 °C on Elecsys 1010/2010: up to 5 hours
• MODULAR ANALYTICS E170: use only once |
Continued on next page
1 The Elecsys® Anti-TPO CalSet was originally cleared as part of the Elecsys® Anti-TPO test system on K051890 and is currently sold to customers as part of the Elecsys Anti-TPO assay kit. As such, the Intended Use of the assay reagent kit is listed in Table 1. Upon clearance of the modified Elecsys® Anti-TPO CalSet device, it will be packaged and sold separately from the assay kit.
2
510(k) Summary, Continued
The Elecsys® Anti-TPO CalSet is currently sold to customers as part of the Comparison table, continued Elecsys® Anti-TPO assay kit. Upon clearance of the modified Elecsys® Anti-TPO CalSet device, it will be packaged and sold separately from the Elecsys® Anti-TPO assay kit. Table 1 below compares Elecsys® Anti-TPO CalSet (K103171) with the predicate device, Elecsys® Anti-TPO CalSet (cleared as part of the Elecsys®
Anti-TPO Test System on K051890).
| Characteristic | Elecsys® Anti-TPO CalSet
(Candidate Device, K103171) | Elecsys® Anti-TPO CalSet
(K051890) |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Handling | Dissolve carefully the contents of one
bottle by adding exactly 1.5 mL of
distilled or deionized water and allow
to stand closed for 15 minutes to
reconstitute. Mix carefully, avoiding
the formation of foam. Transfer the
reconstituted calibrator into the empty
labeled snap-cap bottles supplied. | The reagents in the kit are ready for use and
supplied in the bottles compatible with the system.
Elecsys 1010/2010 analyzers: The Elecsys
calibrators Cal1 and Cal2 and the Elecsys controls²
PC A-TPO1 and PC A-TPO2 should only be left
on the analyzers at 20-25°C during
calibration/quality control. After use, close the
bottles as soon as possible and store at 2-8°C. |
| | Elecsys 2010 and cobas e 411
analyzers: The calibrators should only
be left on the analyzers during
calibration at 20-25°C. Perform only
one calibration procedure per aliquot.
If necessary, freeze in aliquots; see
section on MODULAR ANALYTICS
E170 and cobas e 601 analyzers. | Ensure that no calibration and control solution is
trapped in the opened snap-cap. Because of
possible evaporation effects, not more than 5
calibration/quality control procedures per bottle set
should be performed. |
| | MODULAR ANALYTICS E170 and
cobas e 601 analyzers: Unless the
entire volume is necessary for
calibration on the analyzer, transfer
aliquots of the reconstituted calibrator
into empty snap-cap bottles (CalSet
Vials). Attach the supplied labels to
these additional bottles. Store the
aliquots for later use at -20°C. Perform
only one calibration procedure per
aliquot. | MODULAR ANALYTICS E170 analyzer: Unless
the entire volume is necessary for calibration and
quality control on the analyzer, transfer aliquots of
the ready-for-use calibrators and controls into
empty snap-cap bottles (CalSet Vials/ControlSet
Vials). Attach the supplied labels to these
additional bottles. Store the aliquots for later use at
2-8°C. Perform only one calibration or control
procedure per aliquot. |
| | | All information required for correct operation is
read in via the respective reagent barcodes. |
Table 1. Comparison of Candidate and Predicate Devices, continued
Continued on next page
2 The control materials originally sold with the Elecsys® Anti-TPO test system (PC A-TPO1 and PC A-TPO2) are no longer included in the assay kit. A new control material, Elecsys® PreciControl ThyroAB, was cleared on K092320 and includes the appropriate levels of anti-TPO for quality control of the Elecsys® Anti-TPO assay.
3
【
510(k) Summary, Continued
| Performance
| characteristics | The Elecsys® Anti-TPO CalSet was evaluated for value assignment, stability, and reconstitution. |
|---|---|
| Conclusion | The data demonstrate that the performance of the Elecsys® Anti-TPO CalSet is substantially equivalent to that of the predicate device, Elecsys® Anti-TPO CalSet (cleared as part of the Elecsys® Anti-TPO Test System on K051890). |
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of a bird in flight, with its wings spread. The bird is composed of three curved lines, and it appears to be soaring upwards.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
FEB 1 1 201
Roche Diagnostics c/o Ms. Sarah Baumann Regulatory Affairs Consultant 9115 Hague Road Indianapolis. IN 46250-0416
Re: K103171
Trade/Device Name: Elecsys® Anti-TPO CalSet Regulation Number: 21 CFR 8862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIX Dated: January 06, 2011 Received: January 07, 2011
Dear Ms. Baumann:
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 class II (Special Controls), 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
5
Page 2 - Ms. Sarah Baumann
CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device 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). 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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
ia m Clark
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use Form
510(k) Number (if known): K/ 0 3/7/
Device Name: Elecsys Anti-TPO CalSet
Indications for Use: Elecsys Anti-TPO CalSet is used for calibrating the quantitative Elecsys Anti-TPO assay on the Elecsys and cobas e immunoassay analyzers.
Prescription Use Over-The-Counter Use × Prescription Ose
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Geena Philip
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) /0.3/7/
Page 1 of.