(48 days)
No
The document describes a calibration control for an immunoassay analyzer, which is a standard laboratory product and does not mention any AI/ML components.
No
The device is described as an "assayed control for use in calibration verification and for use in the verification of the assay range" of a quantitative assay reagent, and is for "in vitro diagnostic use only." This indicates it's used for quality control in lab testing, not for treating a disease or condition in a patient.
No
The device is described as 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". This indicates it is used to check the performance of a diagnostic assay, not to diagnose a condition itself.
No
The device description clearly states it is a "lyophilized product consisting of T3 in human serum matrix," indicating it is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states "for in vitro diagnostic use only."
- Function: The device is an assayed control used for calibration verification and assay range verification of a quantitative assay reagent. These are activities performed in a laboratory setting to ensure the accuracy and reliability of diagnostic tests.
- Matrix: The device is in a human serum matrix, which is a common component of IVD controls and calibrators.
The information provided strongly indicates that this device is intended to be used in a laboratory setting to support the performance of an in vitro diagnostic test (the Elecsys T3 quantitative assay).
N/A
Intended Use / Indications for 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, for in vitro diagnostic use only.
Product codes
JJX
Device Description
The Elecsys T3 CalCheck 5 is a lyophilized product consisting of T3 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
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
The Elecsys T3 CalCheck 5 was evaluated for value assignment and stability.
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
| JUL 2 1 2011 | |
|---|---|
| 510(k) Summary | K111552 |
| 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: Kelly French | |
| Phone: 317-521-3208 | |
| Fax: 317-521-2324 | |
| Email: kelly.french@roche.com | |
| Secondary Contact: Stephanie Greeman | |
| Phone: 317-521-2458 | |
| Fax: 317-521-2324 | |
| Email: stephanie.greeman@roche.com | |
| Date Prepared: June 2, 2011 | |
| Device Name | Proprietary name: Elecsys T3 CalCheck 5 |
| Common name: T3 CalCheck 5 | |
| Classification name: Single (specified) analyte controls (assayed and | |
| unassayed) | |
| Predicate | |
| device | The Elecsys T3 CalCheck 5 is substantially equivalent to other products in |
| commercial distribution intended for similar use. We claim equivalency to the | |
| currently marketed T3 CalCheck (K963167). | |
| Device | |
| Description | The Elecsys T3 CalCheck 5 is a lyophilized product consisting of T3 in |
| human serum matrix. During manufacture, the analyte is spiked into the | |
| matrix at the desired concentration levels. | |
| 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, for in vitro diagnostic use only. |
Continued on next page
1
510(k) Summary, Continued
The table below compares Elecsys T3 CalCheck 5 with the predicate device, Comparison Elecsys T3 CalCheck (K963167). The predicate shows that T3 CalCheck 5 is Table substantially equivalent to T3 CalCheck, with several key similarities, especially the analyte. The shaded fields indicate similar characteristics between the candidate device and the predicate device.
| Characteristic | Elecsys T3 CalCheck 5
(Candidate Device) | Elecsys T3 CalCheck
(K963167) |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | For use in the verification of
the calibration established by
the Elecsys T3 regent on
indicated Elecsys and cobas e
immunoassay analyzers. |
| Analyte | T3 | T3 |
| Levels | Five | Three |
| Assay Measuring
Range | 0.300 - 10.0 nmol/L | 0.300 - 10.0 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: 0 ng/ml
Check 2: 1.6 ng/ml
Check 3: 5.8 ng/ml |
| Format | Lyophilized | Lyophilized |
| 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. | Reconstitute Check 1, Check
2, and Check 3 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 hours | Unopened:
• Store at 2-8°C until
expiration date
Reconstituted:
• 15-25°C: 4 hours |
| Matrix | Human serum matrix | Human serum matrix |
Continued on next page
2
510(k) Summary, Continued
Performance The Elecsys T3 CalCheck 5 was evaluated for value assignment and Characteristics stability.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure with stylized feathers.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
JUL 2 1. 2011
Roche Diagnostics c/o Ms. Kelly French Manager, Regulatory Affairs 9115 Hague Road, PO Box 50416 Indianapolis, IN 46250-0416
Re: k11552
·
Trade Name: Elecsys T3 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: June 2, 2011 Received: June 3, 2011
Dear Ms. French:
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 10 woo varior 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 Acts 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).
4
Page 2 -
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,
C.C.
Courtney 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
5
Indication for Use
510(k) Number (if known):
KIII FRA
Device Name: Elecsys T3 CalCheck 5
Indication For 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 reagent on 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)
Richard Glenn Coffey
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K 111 552