(28 days)
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.
Roche Diagnostics Elecsys FSH II CalSet consists of lyophilized human serum with added human FSH in two concentration ranges.
The provided text is a 510(k) summary for the "Elecsys FSH II CalSet" and does not contain information on acceptance criteria or a study proving the device meets those criteria. A 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria.
Therefore, I cannot extract the requested information from the given document. The document describes the device, its intended use, and compares it to a predicate device to claim substantial equivalence, which is the primary purpose of a 510(k) submission. It does not include details on formal acceptance criteria, device performance metrics, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance assessments.
{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 forcalibrating the quantitativeElecsys FSH assay on the Elecsys1010 and 2010 immunoassay andModular Analytics E170 systems. | Elecsys FSH CalSet II is used forcalibrating the quantitativeElecsys FSH assay on the Elecsys1010 and 2010 immunoassay andModular Analytics E170 systems. |
| Levels | Two levels | Two levels |
| Format | Lyophilized | Lyophilized |
| Matrix | Human serum matrix with addedhuman FSH | Equine serum matrix with addedhuman FSH |
| Stability | Unopened:• Stable at 2-8° C untilexpiration dateReconstituted:• -20° C for 3 months(only freeze once)• On analyzer use once only | Unopened:• Stable at 2-8° C untilexpiration dateReconstituted:• -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
§ 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.