(25 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, or any related concepts in the intended use, device description, or performance studies.
No.
The device is a calibrator intended to quantify hGH levels, not to treat or diagnose a condition.
No
The device described, "Access Ultrasensitive hGH Calibrators," is explicitly stated as intended to "calibrate the Access Ultrasensitive hGH Assay." Calibrators are used to ensure the accuracy and reliability of a test, not to perform the diagnostic measurement itself. The diagnostic device would be the "Access Ultrasensitive hGH Assay" and the "Access Immunoassay Systems."
No
The device description clearly states that the device is a kit containing lyophilized calibrators in vials, 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 the device is for the "quantitative determination of hGH levels in human serum and plasma". This involves testing biological samples (serum and plasma) outside of the body (in vitro).
- Device Description: The description details the use of the calibrators with an "Access Ultrasensitive hGH assay" on "Access Immunoassay Systems". Immunoassays are a common method used in IVD testing to measure specific substances in biological samples.
- Performance Studies: The performance studies mention "validation testing" and comparison to "currently commercialized Access Ultrasensitive hGH calibrators", which are typical activities for demonstrating the performance of an IVD.
- Predicate Device: The mention of a predicate device (K003089; Access Ultrasensitive hGH Calibrators) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory submission process for new IVDs.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Access Ultrasensitive hGH Calibrators are intended to calibrate the Access Ultrasensitive hGH Assay for the quantitative determination of hGH 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 Ultrasensitive hGH calibrators are lyophilized calibrators to be used with the Access Ultrasensitive hGH assay to generate the hGH calibration curve on the Access Immunoassay Systems. The Access Ultrasensitive hGH calibrator kit contains six 2.0 mL vials, one for each calibrator level. The Access Immunoassay Systems utilize a one-step immunoenzymatic ("sandwich") assay for the quantitative measurement of hGH.
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
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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 Ultrasensitive hGH Calibrators on the Access Immunoassay Systems is substantially equivalent to the currently commercialized Access Ultrasensitive hGH calibrators.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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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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.
Image /page/0/Picture/4 description: The image shows the text "The assigned 510(k) number is:" followed by the number "K061282". The text is written in a clear, legible font. The number is written in a handwritten style.
Submitter's Name and Address
JUN - 2 2006
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952) 368-7629 Fax: (952) 368-7610 Contact: Jennifer Ruether
Date Prepared: May 5, 2006
Device Names
| Proprietary Name: | Ultrasensitive hGH Calibrators on the Access®
Immunoassay Systems |
| ------------------- | ---------------------------------------------------------------------- |
|---|
Common Name: Calibrators
- Classification Name: Calibrator, Secondary (862.1150, JIT)
Predicate Device
Access Ultrasensitive hGH Calibrators Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
510(k) Number: K003089
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Device Description
The Access Ultrasensitive hGH calibrators are lyophilized calibrators to be used with the Access Ultrasensitive hGH assay to generate the hGH calibration curve on the Access Immunoassay Systems. The Access Ultrasensitive hGH calibrator kit contains six 2.0 mL vials, one for each calibrator level. The Access Immunoassay Systems utilize a one-step immunoenzymatic ("sandwich") assay for the quantitative measurement of hGH.
Intended Use
The Access Ultrasensitive hGH Calibrators are intended to calibrate the Access Ultrasensitive hGH Assay for the quantitative determination of hGH levels in human serum and plasma using the Access Immunoassay Systems.
| Attribute | Access Ultrasensitive hGH Calibrators | Access Ultrasensitive hGH Calibrators (modified) |
|---|---|---|
| Intended Use | Calibration for quantitative determination of hGH levels in human serum and plasma | Calibration for quantitative determination of hGH levels in human serum and plasma |
| Calibrators | hGH at approximate levels of 0.1, 1.0, 10, 20, and 50 ng/mL (µg/L), lyophilized | hGH at approximate levels of 0.07, 0.7, 7, 14, or 35 ng/mL (µg/L), lyophilized |
| Traceability | Traceable to WHO 80/505 | Traceable to WHO 98/574 |
Summary of Technological Characteristics
The device modification consists of restandardizing the Access Ultrasensitive hGH Calibrators from the WHO Pituitary hGH 80/505 standard to the second international standard, WHO 98/574. The restandardization involves the use of the new WHO standard as the reference for assigning the calibrator values; there is no change to calibrator materials, functionality, or stability,
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Conclusion
The restandardization of the Access Ultrasensitive hGH 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 Ultrasensitive hGH Calibrators on the Access Immunoassay Systems is substantially equivalent to the currently commercialized Access Ultrasensitive hGH calibrators.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Jennifer Ruether Regulatory Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
JUN - 2 2006
K061282 Re:
Trade/Device Name: Access Ultrasensitive hGH Calibrators on the Access® Immunoassay Systems Regulation Number: 21 CFR§862.1150 Regulation Name: Calibrator
Regulatory Class: Class II Product Code: JIT Dated: May 5, 2006 Received: May 8, 2006
Dear Ms. Ruether:
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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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) 276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Gutz
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): Kd61282
Device Name: Access Ultrasensitive hGH Calibrators on the Access® Immunoassay Systems
Indications For Use:
The Access Ultrasensitive hGH Calibrators are intended to calibrate the Access Ultrasensitive hGH Assay for the quantitative determination of hGH levels in human serum and plasma on the Access Immunoassay Systems.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C Benam
Division Sign-Off
Cice of In Vitro Diagnostic Device Laation and Safery
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