(48 days)
Not Found
Not Found
No
The document describes a set of calibrators for an immunoassay system, which are chemical reagents used for calibration, not a software or hardware device that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
This device is a calibrator used to establish points of reference for measuring estriol levels, which is a diagnostic tool, not a therapeutic intervention.
No
Explanation: This device is described as a set of calibrators used to establish reference points for measuring estriol levels, not as a diagnostic device itself. It facilitates a diagnostic test but does not perform the diagnosis.
No
The device description explicitly states it is a set of "liquid Calibrators," which are physical substances, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "use in the Access Immunoassay System, to establish points of reference that are used in the determination of values in the measurement of estriol levels in human serum." This describes a process performed in vitro (outside the body) on a human sample (serum) to provide diagnostic information (estriol levels).
- Device Description: It's described as "liquid Calibrators to be used with the Access Immunoassay System." Calibrators are essential components of many in vitro diagnostic tests.
- Predicate Device: The predicate device is also named "Beckman Coulter Access Unconjugated Estriol Calibrators," which strongly suggests it's a type of IVD.
The core function of the device is to provide a reference for measuring a substance in a human sample, which is a defining characteristic of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Access Unconjugated Estriol Calibrators set is a device intended for medical purposes for use in the Access Immunoassay System, to establish points of reference that are used in the determination of values in the measurement of estriol levels in human serum.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
The Access® Unconjugated Estriol Calibrators are liquid Calibrators to be used with the Access Immunoassay System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to the Beckman Coulter Access linding of substantial oquivalensitiations already in commercial distribution. Stability Oltraschaltive not . Calibrators support the stability claim of a minimum of 24 months.
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.
Beckman Coulter Access Unconjugated Estriol Calibrators
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
Image /page/0/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized, circular graphic on the left, with the words "BECKMAN" stacked on top of "COULTER" to the right of the graphic. The text is in a bold, sans-serif font, and the entire logo is in black and white.
510(k) Summary Prepared 27 August 2001
Applicant's Name and Address
Beckman Coulter, Inc. 1000 Lake Hazeltine Dr. Chaska, MN 55318
Mara Caler Contact Person: 858 621 4583
Alternate Contact Person: Denise Thompson 952 368 1202
Device Name
Trade Name - Access® Unconjugated Estriol Calibrators on the Access® Immunoassay Systems Common Name - Unconjugated Estriol Calibrators Classification name - Calibrators (21 CFR 862.1150)
Predicate Device
Beckman Coulter Access Unconjugated Estriol Calibrators
Device Description
The Access® Unconjugated Estriol Calibrators are liquid Calibrators to be used with the Access Immunoassay System.
Intended Use
The Access Unconjugated Estriol Calibrators set is a device intended for medical purposes for use in the Access Immunoassay System, to establish points of reference that are used in the determination of values in the measurement of estriol levels in human serum.
1
Image /page/1/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a black circle with two white curved lines inside, resembling a stylized eye or a wave. To the right of the circle, the words "BECKMAN" and "COULTER" are stacked vertically in a bold, sans-serif font. The overall design is simple and modern, conveying a sense of precision and innovation.
Comparison to Predicate:
Data is presented to demonstrate substantial equivalence to the predicate.
Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to the Beckman Coulter Access linding of substantial oquivalensitiations already in commercial distribution. Stability Oltraschaltive not . Calibrators support the stability claim of a minimum of 24 months.
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing right, with flowing lines connecting them, resembling a bird-like shape.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 6 2001
Ms. Mara Caler Regulatory Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
Re: K012900
Trade/Device Name: Access® Unconjugated Estriol Calibrators Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: August 27, 2001 Received: August 29, 2001
Dear Ms. Caler:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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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Image /page/4/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a circular graphic on the left and the words "BECKMAN COULTER" on the right. The graphic is a black circle with two white curved lines inside. The text is in a bold, sans-serif font, with "BECKMAN" on top and "COULTER" below.
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510(k) Number (if known): KO12900
Device Name: Access® Unconjugated Estriol Calibrators
Indications For Use:
The Access Unconjugated Estriol Calibrators set is a device intended for The Access Onconjuguted Estiler Salishmonoassay System, to establish medical purposes to: essare used in the determination of values in the measurement of estriol levels in human serum.
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use t (Per 21 CFR 801.109) OR
Over-The Counter Use_
Kesia Alexander for Jean Corpor
(Division Sign-Off)
boratory Devices Vision of Clinical La 140 2400 510(k) Number
(Optional Format 1-2-96)