(48 days)
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.
The Access® Unconjugated Estriol Calibrators are liquid Calibrators to be used with the Access Immunoassay System.
This document outlines the 510(k) summary for the Beckman Coulter Access® Unconjugated Estriol Calibrators. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance data in the format requested.
Therefore, many of the requested sections (Table of Acceptance Criteria, Sample Size for Test Set, Number of Experts, Adjudication Method, MRMC study, Standalone study, Type of Ground Truth, Training Set Size, and Training Set Ground Truth establishment) cannot be directly extracted from the provided text.
Based on the information provided, here's what can be gathered:
1. A table of acceptance criteria and the reported device performance
The document states, "Data is presented to demonstrate substantial equivalence to the predicate." And "Calibrators support the stability claim of a minimum of 24 months." However, specific quantitative acceptance criteria (e.g., precision, accuracy, linearity targets) and their corresponding performance values are not detailed in the provided text. The submission focuses on demonstrating substantial equivalence to a previously marketed device rather than providing a new performance study against pre-defined acceptance criteria for a novel device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for any testing or the data provenance. It generally refers to "data in the Premarket Notification on safety and effectiveness."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable as the device is a set of calibrators for an immunoassay system, not an AI-powered diagnostic tool requiring human reader intervention or improvement analysis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a set of calibrators, not an algorithm. However, calibration performance would be assessed in a "standalone" sense of the calibrator's ability to accurately define the reference points for the immunoassay system. The document states, "Data is presented to demonstrate substantial equivalence to the predicate." which implies performance testing was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For calibrators, the "ground truth" would typically be derived from highly accurate reference methods or certified reference materials used to assign values to the calibrator levels. This specific detail is not explicitly stated in the provided text.
8. The sample size for the training set
This is not applicable as the device is a set of calibrators, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated in point 8.
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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.
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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.
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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 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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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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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)
§ 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.