The Access Folate Calibrators are intended to calibrate the Access Folate assay for the quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells using the Access Immunoassay Systems.

Device Description

The Access Folate Calibrators are a six level calibrator set intended to calibrate the Access Folate assay for the quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells using the Access Immunoassay System. The calibrator set provides calibrators at six levels - zero and approximately 1.2. 3.1. 6.2, 12.4 and 24.8 ng/mL (2.8, 7.0, 14.0, 28.1, and 56.2 nmol/L). The calibrators are contained in 4.0 mL vials. The calibrator vials are intended for storage at -20°C or colder.

Calibration cards are provided with each calibrator kit. Calibration cards contain bar codes that are encrypted with the individual calibrator concentrations for each calibrator level.

Folate Calibrator S0 is intended for use with Access Folate assay to dilute patient samples containing analyte concentrations greater than the analyte specific S5 calibrator. Folate Calibrator S0 is a buffered matrix with human serum albumin (HSA) surfactant, < 0.1% sodium azide, and 0.25% ProClin 300. Contains 0.0 ng/mL (nmol/L) folate.

AI/ML Overview

The provided text describes a 510(k) submission for "Access Folate Calibrators" and compares the new calibrators to a predicate device. However, it does not include a study that proves the device meets specific acceptance criteria in the way a clinical performance study would for a diagnostic device.

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K060774) based on modifications not affecting the intended use or fundamental scientific technology. The "acceptance criteria" discussed are largely in the context of device specifications and the conclusion that the modified device "meets product claims specifications."

Therefore, I cannot fulfill all parts of your request as the information about a dedicated study meeting acceptance criteria, sample sizes for test/training sets, expert involvement, MRMC studies, or specific ground truth methodologies in the context of a performance study is not present.

However, I can extract the available information related to the device characteristics and comparisons.

Here's a breakdown of what can be extracted:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present "acceptance criteria" in the typical sense of a target performance metric (e.g., sensitivity, specificity) derived from a clinical study. Instead, the comparison table acts as a set of specifications for the device, which the new device is stated to meet or be equivalent to.

Attribute	Acceptance Criteria (Predicate Device K060774 Specifications)	Reported Device Performance (New Access Folate Calibrator)
Intended Use	Calibrate Access Folate assay for quantitative determination of folic acid in human serum, plasma (heparin), and red blood cells using Access Immunoassay Systems.	Same
Manufacturer	Beckman Coulter	Same
Storage Temperature after opening	2 - 10°C or colder	Same
Instrumentation/technology	Access Immunoassay Systems	Same
Calibrators Antigen	Folate (pteroylmonoglutamic acid) in buffered matrix	Same
Calibrator Level S0	0 ng/mL (0 nmol/L)	0 ng/mL (0 nmol/L)
Calibrator Level S1	1.0 ng/mL (2.3 nmol/L)	1.2 ng/mL (2.8 nmol/L)
Calibrator Level S2	2.5 ng/mL (5.7 nmol/L)	3.1 ng/mL (7.0 nmol/L)
Calibrator Level S3	5.0 ng/mL (11.3 nmol/L)	6.2 ng/mL (14.0 nmol/L)
Calibrator Level S4	10.0 ng/mL (22.7 nmol/L)	12.4 ng/mL (28.1 nmol/L)
Calibrator Level S5	20 ng/mL (45.3 nmol/L)	24.8 ng/mL (56.2 nmol/L)
Calibrator Range	0 - 20 ng/mL	0 - 25 ng/mL
Shelf life	12 months	6 months

Note: The "reported device performance" in this context refers to the specifications of the new re-standardized calibrator, which are compared against the predicate's specifications to demonstrate equivalence despite some numerical changes in calibrator levels and range. The document states: "Based on the results of the product performance characteristics testing, these calibrators meet product claims specifications."

2. Sample sized used for the test set and the data provenance:

This information is not provided in the document. The submission focuses on device parameters and comparison to a predicate, not a clinical performance study with a distinct test set of patient samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. This type of detail would be relevant for a diagnostic device performance study using expert labels, but not for a calibrator's 510(k) submission based on equivalence.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided. This is not applicable to the type of device and submission described.

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 information is not provided. An MRMC study is completely irrelevant to a calibrator device.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:

This information is not provided. This is not applicable to a calibrator device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not provided in the context of clinical "ground truth." For a calibrator, the "truth" lies in its ability to accurately establish a known concentration for a specific analyte. The document implies that "product performance characteristics testing" was conducted to confirm the calibrators meet their specifications, but the specifics of this testing or any "ground truth" derived from patient samples are not detailed.

8. The sample size for the training set:

This information is not provided. This is not applicable to a calibrator device in the context of machine learning.

9. How the ground truth for the training set was established:

This information is not provided. This is not applicable.

In summary: The provided document is a 510(k) premarket notification for a calibrator device. Its primary purpose is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving diagnostic performance against a clinical "ground truth" through a large-scale clinical study involving patient samples and expert interpretation, which is typical for a diagnostic AI/CAD device. Therefore, many of the requested details are not present as they are not relevant to this type of device submission. The "acceptance criteria" are implied by the comparison to the predicate's specifications and the assertion that "product performance characteristics testing" confirmed the new calibrators meet their claims.

Summary

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111952

Folate Calibrators Safety and Effectiveness 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.

Submitter's Name and Address

Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952) 368-7858 Fax: (952) 368-7610 Contact: Kerrie Oetter

Date Prepared: July 22, 2011

Device Names

Proprietary Name: Access Folate Calibrators Common Name: Calibrator Classification Name: Calibrator

Predicate Device

Access Folate Calibrator Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318

510(k) Number: K060774

Device Description

Calibration cards are provided with each calibrator kit. Calibration cards contain bar codes that are encrypted with the individual calibrator concentrations for each calibrator level.

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Intended Use

Attribute	Access Folate Calibrator(K060774)	Access Folate Calibrator(restandardized)
Intended Use	The Access Folate Calibratorsare intended to calibrate theAccess Folate assay for thequantitative determination offolic acid levels in humanserum, plasma (heparin) andred blood cells using the AccessImmunoassay Systems.	Same
Manufacturer	Beckman Coulter	Same
StorageTemperatureafter opening	2 - 10°C or colder	Same
Instrumentation/ technology	Access Immunoassay Systems	Same
CalibratorsAntigen	Folate (pteroylmonoglutamicacid) in buffered matrix	Same
Calibrator LevelS0	0 ng/mL0 nmol/L	0 ng/mL0 nmol/L
Calibrator LevelS1	1.0 ng/mL2.3 nmol/L	1.2 ng/mL2.8 nmol/L
Calibrator LevelS2	2.5 ng/mL5.7 nmol/L	3.1 ng/mL7.0 nmol/L
Calibrator LevelS3	5.0 ng/mL11.3 nmol/L	6.2 ng/mL14.0 nmol/L
Calibrator LevelS4	10.0 ng/mL22.7 nmol/L	12.4 ng/mL28.1 nmol/L
Calibrator LevelS5	20 ng/mL45.3 nmol/L	24.8 ng/mL56.2 nmol/L
CalibratorRange	0 - 20 ng/mL	0 - 25 ng/mL
Self life	12 months	6 months

Comparison to Predicate

Conclusion

The Access Folate Calibrators has been demonstrated to be equivalent to the predicate device. Based on the results of the product performance characteristics testing, these calibrators meet product claims specifications. The modifications do not affect the intended use or indications of the device or alter the fundamental scientific technology of the device. The modifications do not affect the safety and efficacy of the device.

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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 features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

19 2011

Beckman Coulter, Inc. c/o Kerrie S. Oetter Senior Regulatory Affairs Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive MS R-275-B Chaska, MN 55318-1084, USA

Re: K111952 Trade/Device Name: Access Folate Calibrators Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: July 8, 2011 Received: July 11, 2011

Dear Ms. Oetter:

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).

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.

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Page 2 -

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

C.C.

Courtney Harper, 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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Beckman Coulter, Inc. Abbreviated 510(k): Restandardized Access Folate Calibrators July 2011

Access Folate Confidential

Indications for Use Form

KIII952 510(k) Number (if known):

Device Name: Access Folate Calibrators on the Access® Immunoassay Systems

Indications For Use:

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)

Division Sign Off

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K111952

Page 1 of 1

Regulation Number and Section

§ 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.