(28 days)
Not Found
No
The summary describes a calibration set for an immunoassay, which is a standard laboratory reagent and does not involve AI/ML technology. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is a calibrator for an assay, not a device used for therapy or treatment.
No
Explanation: The device is a "CalSet" used for calibrating an assay, not for diagnosing a condition in a patient. It is part of the testing process, ensuring the accuracy of the diagnostic device, rather than being the diagnostic device itself.
No
The device description explicitly states it consists of lyophilized human serum, which is a physical substance, not software.
Based on the provided information, the Elecsys FSH II CalSet is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's used for calibrating a quantitative Elecsys FSH assay. Assays performed on systems like the Elecsys 1010, 2010, and Modular Analytics E170 are used to measure substances in biological samples (like serum), which is a core function of in vitro diagnostics.
- Device Description: The device consists of lyophilized human serum with added human FSH. This material is designed to interact with biological samples or reagents in a laboratory setting to facilitate a diagnostic test.
- Predicate Device: The mention of a predicate device (K003409; Elecsys FSH CalSet II) strongly suggests that this device is also an IVD, as predicate devices are used to demonstrate substantial equivalence for regulatory purposes, typically within the same device classification (in this case, IVDs).
While the document doesn't provide details about performance studies or specific metrics, the intended use and nature of the device clearly align with the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Elecsys FSH II CalSet is used for calibrating the quantitative Elecsys FSH assay on the Elecsys 1010 and 2010 immunoassay and Modular Analytics E170 systems.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
Roche Diagnostics Elecsys FSH II CalSet consists of Iyophilized human serum with added human FSH in two concentration ranges.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
AUG 2 4 2001
510(k) Summary
According to the requirements established in the Food and Drug Introduction Administration's guidance document entitled "The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications", the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. Roche Diagnostics Corporation Submitter name, address, 9115 Hague Road contact Indianapolis, IN 46250 (317) 521 - 3831 Contact Person: Sherri L. Coenen Date Prepared: July 25, 2001 Device Name Proprietary name: FSH II CalSet Common name: Calibrator Classification name: Calibrator, secondary Predicate We claim substantial equivalence to the currently marketed Elecsys FSH Device CalSet II (K003409). Device Roche Diagnostics Elecsys FSH II CalSet consists of Iyophilized human Description serum with added human FSH in two concentration ranges.
27
1
510(k) Summary, Continued
Roche Diagnostics Elecsys FSH II CalSet is used for calibrating the Intended use quantitative Elecsys FSH assay on the Elecsys 1010 and 2010 immunoassay and Modular Analytics E170 systems. and the comments of the more of the many of the many of the many of the first and the The table below indicates the similarities between the modified Elecsys FSH Substantial II CalSet and the predicate, Elecsys FSH CalSet II (K003409). In summary, Equivalence the Elecsys FSH II CalSet described in this submission is, in our opinion,
Comparison of Proposed and Predicate Device
substantially equivalent to the predicate device.
| Topic | Elecsys FSH II CalSet
(Proposed Device) | Elecsys FSH CalSet II
(K003409) |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Elecsys FSH II CalSet is used for
calibrating the quantitative
Elecsys FSH assay on the Elecsys
1010 and 2010 immunoassay and
Modular Analytics E170 systems. | Elecsys FSH CalSet II is used for
calibrating the quantitative
Elecsys FSH assay on the Elecsys
1010 and 2010 immunoassay and
Modular Analytics E170 systems. |
| Levels | Two levels | Two levels |
| Format | Lyophilized | Lyophilized |
| Matrix | Human serum matrix with added
human FSH | Equine serum matrix with added
human FSH |
| Stability | Unopened:
• Stable at 2-8° C until
expiration date
Reconstituted:
• -20° C for 3 months
(only freeze once)
• On analyzer use once only | Unopened:
• Stable at 2-8° C until
expiration date
Reconstituted:
• -20° C for 3 months
(only freeze once)
• On analyzer use once only |
2
Image /page/2/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 a stylized symbol that resembles three abstract human figures or flames.
AUG 2 4 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Sherri L. Coenen Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road PO Box 50457 Indianapolis, IN 46250-0457
K012399 Re:
Trade/Device Name: Elecsys FSH II CalSet Regulation Number: 21 CFR 862.1150 Regulatory Class: II Product Code: JIT Dated: July 25, 2001 Received: July 27, 2001
Dear Ms. Coenen:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket I his lotter will and hy of substantial equivalence of your device to a legally marketed nouticate 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 Part 801 and 1 If you desire specific as in vitro diagnostic devices), please contact the Office of Compliance at additionally 007.10 101 ------------------------------------------------------------------------------------------------------------------------------------------------------(301) 59 mot the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small miorination on Jour respeal and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): N/A
Device Name: Elecsys FSH II CalSet
Indications For Use:
Elecsys FSH II CalSet is used for calibrating the quantitative Elecsys FSH assay on the Elecsys 1010 and 2010 immunoassay and Modular Analytics E170 systems.
Prescription Use _ (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Kesia Alexander for Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K012399