(56 days)
Not Found
No
The summary describes a set of calibrators for an immunoassay system, which is a standard laboratory technique. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text.
No
The device is a calibrator for an assay that measures estradiol levels, which is a diagnostic tool, not a therapeutic one.
No
The device is described as "calibrators" used to calibrate an assay for quantitative determination of estradiol levels. It is a control substance for a diagnostic assay, not a diagnostic device itself.
No
The device description clearly states the device is a kit containing six vials of liquid calibrators, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the calibrators are used to calibrate an assay for the "quantitative determination of estradiol levels in human serum and plasma." This indicates the device is used to analyze biological samples in vitro (outside the body).
- Device Description: The description confirms the device is a "liquid calibrator to be used with the Access Estradiol assay" on an "Access Immunoassay System." This further supports its use in a laboratory setting for in vitro testing.
- Predicate Device: The mention of "Access Estradiol Calibrators" as predicate devices, which are typically IVDs, also points to this device being an IVD.
The core function of calibrators in an immunoassay is to establish a relationship between the signal generated by the assay and the concentration of the analyte (estradiol in this case) in the sample. This is a fundamental step in in vitro diagnostic testing to ensure accurate and reliable results.
N/A
Intended Use / Indications for Use
The Access Estradiol Calibrators are intended to calibrate the Access Estradiol assay for the quantitative determination of estradiol levels in human serum and plasma using the Access Immunoassay Systems.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
The Access Estradiol Calibrators are liquid calibrators to be used with the Access Estradiol assay to generate the estradiol calibration curve on the Access Immunoassay Systems. The Access Estradiol Calibrator kit contains six vials, one for each calibrator level. The Access Immunoassay Systems utilize a competitive binding immunoenzymatic assay for the quantitative measurement of estradiol.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data generated from validation testing demonstrates that the restandardized Access Estradiol Calibrators on the Access Immunoassay Systems is substantially equivalent to the currently commercialized Access Estradiol Calibrators.
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.
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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).
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§ 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.
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MAR 1 9 2008
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K080166
Submitter's Name and Address
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952) 368-7899 Fax: (952) 368-7610 Contact: Jeffrey L. Koll
Date Prepared: March 11, 2008
Device Names
| Proprietary Name: | Access® Estradiol Calibrators on the Access®
Immunoassay Systems |
|----------------------|---------------------------------------------------------------------|
| Common Name: | Calibrators |
| Classification Name: | Calibrator, Secondary (862.1150. JIT) |
Predicate Device
Access Estradiol Calibrators Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
510(k) Number: K973743, K970126
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Device Description
The Access Estradiol Calibrators are liquid calibrators to be used with the Access Estradiol assay to generate the estradiol calibration curve on the Access Immunoassay Systems. The Access Estradiol Calibrator kit contains six vials, one for each calibrator level. The Access Immunoassay Systems utilize a competitive binding immunoenzymatic assay for the quantitative measurement of estradiol.
Intended Use
The Access Estradiol Calibrators are intended to calibrate the Access Estradiol assay for the quantitative determination of estradiol levels in human serum and plasma using the Access Immunoassay Systems.
| Attribute | Access Estradiol
Calibrators | Access Estradiol
Calibrators
(restandardized) |
|--------------|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Intended Use | Calibration for quantitative
determination of estradiol
levels in human serum and
plasma | No Change |
| Calibrators | Estradiol at approximate
levels of 100, 500, 1500,
2500, and 3600 pg/mL,
liquid | Estradiol at approximate
levels of 106, 570, 1800,
3100, and 4800 pg/mL, liquid |
| Traceability | Traceable to USP reference
material | Traceable to ID-GC/MS
(isotope dilution-gas
chromatography/mass
spectrometry) reference
method |
Summary of Technological Characteristics
The device modification consists of restandardizing the Access Estradiol Calibrators traceability from USP reference material to the ID-GC/MS reference method. There is no change to calibrator materials, functionality, or stability.
2
Conclusion
The restandardization of the Access Estradiol Calibrators does not change the intended use or indications for use, alter the fundamental scientific technology, or affect the safety and efficacy of the device. Performance data generated from validation testing demonstrates that the restandardized Access Estradiol Calibrators on the Access Immunoassay Systems is substantially equivalent to the currently commercialized Access Estradiol Calibrators.
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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 stylized eagle or bird symbol, with three curved lines representing the wings and body. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 9 2008
Beckman Coulter, Inc. c/o Mr. Jeffrey L. Koll Regulatory Specialist 1000 Lake Hazeltine Drive Chaska, MN 55318-1084
Re: K080166
Trade/Device Name: Access® Estradiol Calibrators on the Access® Immunoassay Systems Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrators Regulatory Class: Class II Product Code: JIT Dated: February 19, 2008 Received: February 20, 2008
Dear Mr. Koll:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yéan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known):
Device Name: Access® Estradiol Calibrators on the Access® Immunoassay Systems
Indications For Use:
The Access Estradiol Calibrators are intended to calibrate the Access Estradiol assay for the quantitative determination of estradiol levels in human serum and plasma using the Access Immunoassay Systems.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benson
Sign-Off
Page 1 of 1
Office of In Vitro Diagnosti bation a
080166