(21 days)
For the calibration of the quantitative estradiol assay on the Elecsys 1010 and 2010 immunoassay systems.
Roche Diagnostics Elecsys® Estradiol CalSet II consists of lyophilized human serum with added estradiol in two concentration ranges.
The provided text describes a 510(k) summary for the "Elecsys® Estradiol CalSet II" but does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The document focuses on:
- Introduction to the device: Elecsys® Estradiol CalSet II, an in vitro diagnostic calibrator.
- Intended Use: For the calibration of the quantitative estradiol assay on the Elecsys® 1010 and 2010 immunoassay systems.
- Substantial Equivalence: A comparison to a predicate device (Elecsys® Estradiol CalSet) outlining similarities (intended use, two levels) and differences (format, matrix, stability).
- FDA Clearance: The letter from the FDA granting clearance based on substantial equivalence.
Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets the acceptance criteria from the given text.
The document is a regulatory submission for device clearance, not a performance study report with acceptance criteria.
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SEP 2 4 1999
510(k) Summary – Elecsys® Estradiol CalSet II
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
|---|---|
| Submittername, address,contact | Roche Diagnostics Corporation9115 Hague RdIndianapolis IN 46250(317) 576 3723 |
| Contact person: Priscilla A. Hamill | |
| Date prepared: September 1, 1999 | |
| Predicatedevice | Roche Diagnostics Elecsys® Estradiol CalSet II is substantially equivalent toother devices legally marketed in the United States. We claim equivalence tothe currently marketed Roche Diagnostics Elecsys® Estradiol CalSet. |
| Devicedescription | Roche Diagnostics Elecsys® Estradiol CalSet II consists of lyophilizedhuman serum with added estradiol in two concentration ranges. |
| Intended use /Indication foruse | Roche Diagnostics Elecsys® Estradiol CalSet II is intended for the calibrationof the quantitative estradiol assay on the Elecsys ® 1010 and 2010immunoassay systems. |
| Substantialequivalence | Elecsys® Estradiol CalSet II is equivalent to other devices legally marketedin the United States. We claim equivalence to the currently marketed RocheDiagnostics Elecsys® Estradiol CalSet cleared under document K965109. |
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510(k) Summary - Elecsys® Estradiol CalSet II, continued
The following table compares Elecsys® Estradiol CalSet II, with the Substantial predicate device (currently marketed modified Elecsys® Estradiol CalSet). equivalence similarities
| Characteristic | Elecsys® Estradiol CalSet II(Modified Device) | Elecsys® Estradiol CalSet(Predicate Device) |
|---|---|---|
| Intended Use | For the calibration of thequantitative estradiol assay onthe Elecsys 1010 and 2010immunoassay systems. | For the calibration of thequantitative estradiol assay onthe Elecsys 1010 and 2010immunoassay systems. |
| Levels | Two levels | Two levels |
Comparison of Modified Device and Predicate Device
Substantial equivalence dífferences —
Comparison of Modified Device and Predicate Device
| Characteristic | Elecsys® Estradiol CalSet II(Modified Device) | Elecsys® Estradiol CalSet(Predicate Device) |
|---|---|---|
| Format | Lyophilized | Liquid, ready to use |
| Matrix | Human serum with addedestradiol | Buffer/protein |
| Stability | UnopenedStable at 2-8° C untilexpiration date Reconstituted:✓ -20° - 3 months✓ On analyzer - 3 hours | UnopenedStable at 2-8° C untilexpiration date Opened✓ 2-8° C – 12 weeks✓ On analyzer - 5 hours |
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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 stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol. The logo is in black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 2 4 1999
Ms. Priscilla A. Hamill Regulatory Affairs, Laboratory Systems Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
Re: K992981
Trade Name: Elecsys® Estradiol CalSet II Regulatory Class: II Product Code: JIT Dated: September 1, 1999 Received: September 3, 1999
Dear Ms. Hamill:
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 (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). 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): N/A
K99298
Device Name: Elecsys® Estradiol CalSet II
Indications For Use:
For the calibration of the quantitative estradiol assay on the Elecsys 1010 and 2010 immunoassay systems.
Jean Cooper
(D (Sign-Off)
E
of Clinical Laboratory Les
$16mber K992481
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| (Optional Format 1-2- |
૭૮)
§ 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.