ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS

K112603 · Beckman Coulter, Inc. · JJX · Nov 4, 2011 · Clinical Chemistry

Device Facts

• Record ID: K112603
• Device Name: ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS
• Applicant: Beckman Coulter, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Nov 4, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Access Hybritech p2PSA QC are tri-level controls intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of [-2]proPSA isoform of Prostate Specific antigen (PSA) using the Access Immunoassay Systems.

Device Story

Access Hybritech p2PSA QC are tri-level, ready-to-use controls consisting of a buffered bovine serum albumin (BSA) matrix with preservatives. They are used to monitor the performance of immunoenzymatic procedures for the quantitative measurement of [-2]proPSA on Access Immunoassay Systems. The controls are processed by the system using the same chemiluminescent technology as patient samples. Healthcare providers use the resulting control values to verify that the immunoassay system is performing within established specifications, ensuring the accuracy and reliability of patient test results. The device is intended for laboratory use.

Clinical Evidence

No clinical data. Bench testing only. Stability studies confirmed 12-month shelf life at -20°C and 60-day open-vial stability at 2-10°C. Shipping stability was validated through simulated summer and winter cycles, meeting the ±10% grand mean recovery acceptance criterion.

Technological Characteristics

Tri-level quality control material; buffered bovine serum albumin (BSA) matrix with preservatives; ready-to-use liquid form; chemiluminescent immunoassay technology; stored at 2-10°C; 12-month shelf life.

Indications for Use

Indicated for use as quality control material to monitor the performance of immunoenzymatic procedures for the quantitative measurement of [-2]proPSA isoform of Prostate Specific Antigen (PSA) on Access Immunoassay Systems.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Access Hybritech free PSA QC (k993210)

Submission Summary (Full Text)

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K112603

NOV - 4 2011

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Access Hybritech p2PSA OC 510(k) Summary

#### 1.0 Submitted By:

Cindy McGuire Senior Regulatory Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: [phone] Fax: [phone]

#### 2.0 Date Submitted:

May 1, 2009

#### 3.0 Device Name:

- 3.1 Trade Name Access® Hybritech® p2PSA QC on the Access Immunoassay Systems
- 3.2 Common Name Single (specified) Analyte Controls (Assayed and Unassayed)
- 3.3 Classification Name Quality control material (assayed and unassayed)

#### 4.0 Legally Marketed Device:

The Access Hybritech p2PSA QC claim substantial equivalence to the Access Hybritech free PSA QC on the Access Immunoasay Systems currently in commercial distribution, FDA 510(k) Number k993210

#### 5.0 Device Description:

The Access Hybritech p2PSA OC are tri-level controls intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of [-2]proPSA isoform of Prostate Specific Antigen (PSA) using the Access Immunoassay Systems. The Access Hybritech p2PSA QC kit contains 3 X 5.0 mL bottles, one for each of the three control levels. The Access Immunoassay Systems utilize a "sandwich" immunoenzymatic method for quantitative analyte measurement.

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Image /page/1/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a circular graphic on the left and the company name on the right. The graphic is a stylized representation of an eye or a cell, with two curved lines inside a circle. The text "BECKMAN COULTER" is written in bold, sans-serif font, with "BECKMAN" on the top line and "COULTER" on the bottom line.

#### Intended Use: 6.0

The Access Hybritech p2PSA QC are tri-level controls intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of [-2]proPSA isoform of Prostate Specific Antigen (PSA) using the Access Immunoassay Systems.

#### 7.0 Comparison to the Predicate:

The Access Hybritech p2PSA QC and the predicate Access Hybritech free PSA QC were compared. A comparison of similarities and differences between the two is provided in the tables below.

| Similarities to Predicate Device | | |
|--------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| | Access Hybritech p2PSA QC | Access Hybritech free PSA QC |
| Quality Control Indications | Verify assay performance | Verify assay performance |
| Value assignment | Final concentrations are<br>determined by value assignment<br>using the Access Immunoassay<br>Systems. | Final concentrations are<br>determined by value assignment<br>using the Access Immunoassay<br>Systems. |
| Storage temperature after<br>opening | 2 - 10°C | 2 - 10°C |
| Instrumentation / technology | Access Immunoassay Systems –<br>Chemiluminescent | Access Immunoassay Systems –<br>Chemiluminescent |
| Shelf life | 12 months | 12 months |
| Manufacturer | Beckman Coulter | Beckman Coulter |
| Control matrix | Buffered bovine serum albumin<br>(BSA) matrix with preservatives. | Buffered bovine serum albumin<br>(BSA) matrix with preservatives. |
| Form | Ready to use | Ready to use |

### Similarities between the Access Hybritech p2PSA QC and Predicate Device k993210

Differences between the Access Hybritech p2PSA QC and Predicate Device k993210

| Differences to Predicate Device | | |
|---------------------------------|--------------------------------------|------------------------------------|
| | Access Hybritech p2PSA QC | Access Hybritech free PSA QC |
| Analyte | [-2]proPSA | Free PSA |
| Control antigen source | Recombinant mammalian cell line | Seminal fluid |
| Kit configuration | Three 5.0 mL vials, 1 vial per level | Two 5.0 mL vials, 1 vial per level |
| Control Concentrations | Tri-level controls | Bi-level controls |

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Image /page/2/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a circular graphic on the left and the company name on the right. The graphic is a stylized representation of two curved lines within a circle. The text "BECKMAN" is on the top line and "COULTER" is on the bottom line, with the two words stacked vertically.

#### 8.0 Conclusion:

(

The Access Hybritech p2PSA QC has been demonstrated to be equivalent to the predicate device. Based on the results of the product performance characteristics testing, these controls meet product claims and specifications.

Performance data from validation testing supports a finding of substantial equivalence to the Access Hybritech free PSA QC already in commercial distribution.

Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318-1084

Telephone: [phone] Internet: www.beckmancoulter.com

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, on the right side. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Beckman Coulter, Inc. c/o Ms. Cindy McGuire Senior Regulatory Specialist 1000 Lake Hazeltine Drive Chaska, MN 55318

.. . . .

NOV 0 4 2011

Re: k112603

Trade/Device Name: Access Hybritech p2PSA OC Regulation Number: 21 CFR§862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I (reserved) Product Code: JJX Dated: August 11, 2011 Received: September 07, 2011

Dear Ms. McGuire:

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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice

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Page 2 - Ms. Cindy McGuire

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.

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.

ia m chan

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indication for Use

510(k) Number (if known): K / / 2 6 0 3

Device Name: Access®Hybritech® p2PSA QC

Indication For Use:

The Access Hybritech p2PSA QC are tri-level controls intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of [-2]proPSA isoform of Prostate Specific Antigen (PSA) using the Access Immunoassay Systems.

ﻟﻤﺴﺎ Prescription Use (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Maria Chan

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

510(k) K1112603