(52 days)
Not Found
No
The summary describes calibration and control materials for an immunoassay, which are standard laboratory reagents and do not involve AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
This device is a calibrator and control for an in vitro diagnostic immunoassay, not a therapeutic device.
No
Explanation: The device is described as a calibrator and control for an immunoassay, indicating it is used to ensure the accuracy and reliability of diagnostic tests, rather than being a diagnostic device itself. It helps verify the range and calibration of an assay that perfroms diagnosis, but is not directly diagnostic.
No
The device description explicitly states that the products are "lyophilized products consisting of human growth hormone (hGH) in human serum matrix," indicating a physical, non-software component.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the Elecsys hGH CalSet and CalCheck 5 are used for calibrating and verifying the Elecsys hGH assay, which is a quantitative immunoassay. Immunoassays are laboratory tests performed in vitro (outside the body) to measure substances in biological samples.
- Device Description: The description mentions that the products are lyophilized and consist of human growth hormone in a human serum matrix. This indicates that the device is designed to interact with biological samples (human serum) in a laboratory setting.
- Context of Use: The device is used on "Elecsys and cobas e immunoassay analyzers," which are instruments used for performing in vitro diagnostic tests.
- Predicate Devices: The predicate devices listed (Elecsys C-Peptide CalSet and CalCheck 5) are also IVD devices used for calibration and control in immunoassay testing.
The core function of this device is to support the accurate performance of an in vitro diagnostic test (the Elecsys hGH assay). Therefore, it falls under the definition of an IVD.
N/A
Intended Use / Indications for Use
The Elecsys hGH CalSet is used for calibrating the quantitative Elecsys hGH assay on the Elecsys and cobas e immunoassay analyzers.
The Elecsys hGH 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 hGH reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Product codes
JIT, JJX
Device Description
The Elecsys hGH CalSet and hGH CalCheck 5 are lyophilized products consisting of human growth hormone (hGH) 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Elecsys hGH CalSet and Elecsys hGH CalCheck 5 were 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
§ 862.1150 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
K10322.1
| 510(k) Summary | DEC 22 2010 |
|---|---|
| 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 and Contact Information | Roche Diagnostics |
| 9115 Hague Road, P.O. Box 50416 | |
| 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: October 29, 2010 | |
| Device Name | Proprietary name: (1) Elecsys hGH CalSet |
| (2) Elecsys hGH CalCheck 5 | |
| Common name: (1) hGH CalSet | |
| (2) hGH CalCheck 5 | |
| Classification name: (1) Calibrator, secondary | |
| (2) Single (specified) analyte controls (assayed and unassayed) | |
| Predicate Devices | The Elecsys hGH CalSet is substantially equivalent to other products in commercial distribution for similar use. We claim equivalency to the current marketed Elecsys C-Peptide CalSet (K033873). |
| The Elecsys hGH CalCheck 5 is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys C-Peptide CalCheck 5 (K100810). | |
| Continued on next page |
.
1
510(k) Summary, Continued
| Device
Description | The Elecsys hGH CalSet and hGH CalCheck 5 are lyophilized products
consisting of human growth hormone (hGH) in human serum matrix. During
manufacture, the analyte is spiked into the matrix at the desired concentration
levels. |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Elecsys hGH CalSet is used for calibrating the quantitative Elecsys hGH
assay on the Elecsys and cobas e immunoassay analyzers.
The Elecsys hGH 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 hGH reagent on the indicated Elecsys and cobas e immunoassay
analyzers. |
| Comparison
Tables | The tables below compare the Elecsys hGH CalSet and Elecsys hGH
CalCheck 5 with their predicate devices, Elecsys C-Peptide CalSet (K033873)
and Elecsys C-Peptide CalCheck 5 (K100810), respectively. |
| Elecsys hGH CalSet | Elecsys C-Peptide CalSet | |
|---|---|---|
| Characteristic | (Candidate Device) | (K033873) |
| Intended Use | Elecsys hGH CalSet is used for calibrating | |
| the quantitative Elecsys hGH assay on the | ||
| Elecsys and cobas e immunoassay | ||
| analyzers. | Elecsys C-Peptide CalSet is used for | |
| calibrating the quantitative Elecsys C- | ||
| Peptide assay on the Elecsys and cobas e | ||
| immunoassay analyzers. | ||
| Analyte | Human growth hormone (hGH) | C-Peptide |
| Levels | Two | Same |
| Format | Lyophilized | Same |
| Handling | Add exactly 1.0 mL of distilled or deionized | |
| water and allow to stand closed for 15 | ||
| minutes to reconstitute. Mix carefully, | ||
| avoiding the formation of foam. | Same | |
| Stability | Unopened: | |
| Store at 2-8°C until expiration date | ||
| Reconstituted: | ||
| -20°C: 28 days (freeze only once) On Elecsys 2010 and cobas e 411 | ||
| (20-25°C): | ||
| Up to 5 hours On MODULAR ANALYTICS E170, | ||
| cobas e 601, and cobas e 602: | ||
| Use only once. | Unopened: | |
| Same | ||
| Reconstituted: | ||
| -20°C: 1 month (freeze only once) On analyzers (20-25 °C): | ||
| Use only once. | ||
| Matrix | Human serum matrix | Equine serum matrix |
Table 1. Elecsys hGH CalSet Comparison Table
Continued on next page
2
510(k) Summary, Continued
Comparison Tables, continued
| Characteristic | Elecsys hGH CalCheck 5
(Candidate Device) | Elecsys C-Peptide CalCheck 5
(K100810) |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Elecsys hGH 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 hGH reagent on the indicated Elecsys and cobas e immunoassay analyzers. | The Elecsys C-Peptide 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 C-Peptide reagent on the indicated Elecsys and cobas e immunoassay analyzers. |
| Analyte | Human growth hormone (hGH) | C-Peptide |
| Levels | Five | Same |
| Format | Lyophilized | Same |
| 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. | Same |
| Stability | Unopened:
● Store at 2-8°C until expiration date
Reconstituted:
● 20-25°C: 5 hours | Unopened:
● Same
Reconstituted:
● 20-25°C: 4 hours |
| Matrix | Human serum matrix | Equine serum matrix |
Table 2. Elecsys hGH CalCheck 5 Comparison Table
Performance Characteristics The Elecsys hGH CalSet and Elecsys hGH CalCheck 5 were evaluated for value assignment and stability.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing upwards.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Roche Diagnostics c/o Ms. Kelly Collen O'Maine Adams Regulatory Affairs Specialist 9115 Hague Road, P.O. Box 50416 Indianapolis. IN 46250-0416
Re: K103221
Trade Name: The Elecsys hGH CalSet, The Elecsys hGH CalCheck 5 Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIT, JJX Dated: October 29, 2010 Received: November 01, 2010
DEC 2 3 2010
Dear Ms. O'Maine Adams: ·
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 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-fre ne (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
CJC.
Courmey 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
KI0322/
510(k) Number (if known):
DEC 2 3 2010
Device Name: Elecsys hGH CalSet
f
Indication For Use:
Elecsys hGH CalSet is used for calibrating the quantitative Elecsys hGH assay on the 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) K103221
6
K10322/
Indication for Use
DEC 2 3 2010
510(k) Number (if known):
Device Name: Elecsys hGH CalCheck 5
Indication For Use:
The Elecsys hGH 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 hGH 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)
Carol Benson
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)