ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033

K111952 · Beckman Coulter, Inc. · JIT · Aug 19, 2011 · Clinical Chemistry

Device Facts

• Record ID: K111952
• Device Name: ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033
• Applicant: Beckman Coulter, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Aug 19, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

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 Story

Access Folate Calibrators consist of a six-level set (0 to ~24.8 ng/mL) of buffered matrix containing folate (pteroylmonoglutamic acid), human serum albumin, sodium azide, and ProClin 300. Used to calibrate Access Immunoassay Systems for quantitative folate determination in serum, plasma, and red blood cells. Calibration cards with encrypted bar codes facilitate instrument setup. S0 calibrator also serves as a diluent for high-concentration samples. Stored at -20°C or colder; thawed vials stable at 2-10°C. Provides standardized reference points for clinical laboratory assays, ensuring accurate quantification of patient folate levels.

Clinical Evidence

No clinical data. Bench testing only. Traceability established against USP Folic Acid Reference Standard and WHO International Standard 03/178. Value assignment performed via replicate analysis on Access 2 analyzers with 95% CI. Real-time stability studies confirmed shelf life and storage conditions.

Technological Characteristics

Six-level liquid calibrator set; folate (pteroylmonoglutamic acid) in buffered matrix with human serum albumin, surfactant, <0.1% sodium azide, and 0.25% ProClin 300. Concentrations: 0, 1.2, 3.1, 6.2, 12.4, 24.8 ng/mL. Bar-coded calibration cards for automated system input. Storage: -20°C or colder. Compatible with Access Immunoassay Systems.

Indications for Use

Indicated for use as calibrators for the Access Folate assay to quantify folic acid in human serum, plasma (heparin), and red blood cells. For prescription use on Access Immunoassay Systems.

Regulatory Classification

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.)

Special Controls

*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.

Predicate Devices

• Access Folate Calibrators (k060774)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] 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

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.

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### Intended Use

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.

| Attribute | Access Folate Calibrator<br>(k060774) | Access Folate Calibrator<br>(restandardized) |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Intended Use | The Access Folate Calibrators<br>are intended to calibrate the<br>Access Folate assay for the<br>quantitative determination of<br>folic acid levels in human<br>serum, plasma (heparin) and<br>red blood cells using the Access<br>Immunoassay Systems. | Same |
| Manufacturer | Beckman Coulter | Same |
| Storage<br>Temperature<br>after opening | 2 - 10°C or colder | Same |
| Instrumentation<br>/ technology | Access Immunoassay Systems | Same |
| Calibrators<br>Antigen | Folate (pteroylmonoglutamic<br>acid) in buffered matrix | Same |
| Calibrator Level<br>S0 | 0 ng/mL<br>0 nmol/L | 0 ng/mL<br>0 nmol/L |
| Calibrator Level<br>S1 | 1.0 ng/mL<br>2.3 nmol/L | 1.2 ng/mL<br>2.8 nmol/L |
| Calibrator Level<br>S2 | 2.5 ng/mL<br>5.7 nmol/L | 3.1 ng/mL<br>7.0 nmol/L |
| Calibrator Level<br>S3 | 5.0 ng/mL<br>11.3 nmol/L | 6.2 ng/mL<br>14.0 nmol/L |
| Calibrator Level<br>S4 | 10.0 ng/mL<br>22.7 nmol/L | 12.4 ng/mL<br>28.1 nmol/L |
| Calibrator Level<br>S5 | 20 ng/mL<br>45.3 nmol/L | 24.8 ng/mL<br>56.2 nmol/L |
| Calibrator<br>Range | 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 [phone]. 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 [phone] or [phone] 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:

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.

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

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