(21 days)
Not Found
No
The summary describes a calibration set for an immunoassay system, which is a chemical reagent product, not a software or hardware device that would typically incorporate AI/ML. There are no mentions of AI, ML, or related concepts.
No
The device is a calibrator for an immunoassay system, used to ensure the accuracy of quantitative estradiol assays, not to treat or diagnose a disease.
No
Explanation: The device is used for the "calibration of the quantitative estradiol assay," not for diagnosing a condition in a patient. It is a calibrator for a diagnostic assay.
No
The device description explicitly states it consists of lyophilized human serum, which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "calibration of the quantitative estradiol assay on the Elecsys 1010 and 2010 immunoassay systems." This indicates it's used in vitro (outside the body) to ensure the accuracy of a diagnostic test (the estradiol assay).
- Device Description: The description mentions it consists of "lyophilized human serum with added estradiol." This is a biological material used in a laboratory setting for testing purposes.
- Predicate Device: The predicate device listed (K965109; Roche Diagnostics Elecsys® Estradiol CalSet) is also an IVD, as indicated by its name and the K number which is a premarket notification number for medical devices, including IVDs.
Therefore, based on the provided information, the Roche Diagnostics Elecsys® Estradiol CalSet II is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Roche Diagnostics Elecsys® Estradiol CalSet II is intended for the calibration of the quantitative estradiol assay on the Elecsys ® 1010 and 2010 immunoassay systems.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
Roche Diagnostics Elecsys® Estradiol CalSet II consists of lyophilized human serum with added estradiol 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
SEP 2 4 1999
510(k) Summary – Elecsys® Estradiol CalSet II
| 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 Corporation
9115 Hague Rd
Indianapolis IN 46250
(317) 576 3723 |
| | Contact person: Priscilla A. Hamill |
| | Date prepared: September 1, 1999 |
| Predicate
device | Roche Diagnostics Elecsys® Estradiol CalSet II is substantially equivalent to
other devices legally marketed in the United States. We claim equivalence to
the currently marketed Roche Diagnostics Elecsys® Estradiol CalSet. |
| Device
description | Roche Diagnostics Elecsys® Estradiol CalSet II consists of lyophilized
human serum with added estradiol in two concentration ranges. |
| Intended use /
Indication for
use | Roche Diagnostics Elecsys® Estradiol CalSet II is intended for the calibration
of the quantitative estradiol assay on the Elecsys ® 1010 and 2010
immunoassay systems. |
| Substantial
equivalence | Elecsys® Estradiol CalSet II is equivalent to other devices legally marketed
in the United States. We claim equivalence to the currently marketed Roche
Diagnostics Elecsys® Estradiol CalSet cleared under document K965109. |
1
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 the
quantitative estradiol assay on
the Elecsys 1010 and 2010
immunoassay systems. | For the calibration of the
quantitative estradiol assay on
the Elecsys 1010 and 2010
immunoassay 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 added
estradiol | Buffer/protein |
| Stability | Unopened
Stable at 2-8° C until
expiration date Reconstituted:
✓ -20° - 3 months
✓ On analyzer - 3 hours | Unopened
Stable at 2-8° C until
expiration date Opened
✓ 2-8° C – 12 weeks
✓ On analyzer - 5 hours |
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 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.
3
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
4
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- |
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