K Number
K112603
Device Name
ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS
Date Cleared
2011-11-04

(58 days)

Product Code
Regulation Number
862.1660
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 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.
More Information

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No
The document describes quality control materials for an immunoassay system, which is a standard laboratory technique and does not mention or imply the use of AI or ML.

No.
The device is described as a tri-level control intended for monitoring system performance of immunoenzymatic procedures, indicating it is an in vitro diagnostic (IVD) control rather than a therapeutic device.

No.
The device is described as "tri-level controls intended for monitoring system performance of immunoenzymatic procedures," indicating it is used for quality control of other diagnostic tests rather than directly diagnosing a condition.

No

The device description clearly states it is a "kit" containing "bottles" with "mL" of material, indicating a physical product, not software.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states it's for "monitoring system performance of immunoenzymatic procedures for the quantitative measurement of [-2]proPSA isoform of Prostate Specific Antigen (PSA)". This involves testing samples in vitro (outside the body) to assess the performance of a diagnostic test.
  • Device Description: The description details the use of "immunoenzymatic procedures" and "quantitative analyte measurement," which are characteristic of in vitro diagnostic methods.
  • Predicate Device: The predicate device listed (Access Hybritech free PSA QC) is also an IVD, indicating that this device falls within the same regulatory category.

While the device itself is a control material and not the primary diagnostic test, its purpose is to ensure the accuracy and reliability of an in vitro diagnostic procedure. Therefore, it is considered an IVD.

N/A

Intended Use / Indications 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.

Product codes (comma separated list FDA assigned to the subject device)

JJX

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.

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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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)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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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.

K993210

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.

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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).

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§ 862.1660 Quality control material (assayed and unassayed).

(a)
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.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

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K112603

NOV - 4 2011

Image /page/0/Picture/2 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 an abstract design with two curved lines inside a circle. The text "BECKMAN" is on the top line and "COULTER" is on the bottom line.

i

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: 952.368.1142 Fax: 952.368.7610

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.

1

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 QCAccess Hybritech free PSA QC
Quality Control IndicationsVerify assay performanceVerify assay performance
Value assignmentFinal concentrations are
determined by value assignment
using the Access Immunoassay
Systems.Final concentrations are
determined by value assignment
using the Access Immunoassay
Systems.
Storage temperature after
opening2 - 10°C2 - 10°C
Instrumentation / technologyAccess Immunoassay Systems –
ChemiluminescentAccess Immunoassay Systems –
Chemiluminescent
Shelf life12 months12 months
ManufacturerBeckman CoulterBeckman Coulter
Control matrixBuffered bovine serum albumin
(BSA) matrix with preservatives.Buffered bovine serum albumin
(BSA) matrix with preservatives.
FormReady to useReady 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 QCAccess Hybritech free PSA QC
Analyte[-2]proPSAFree PSA
Control antigen sourceRecombinant mammalian cell lineSeminal fluid
Kit configurationThree 5.0 mL vials, 1 vial per levelTwo 5.0 mL vials, 1 vial per level
Control ConcentrationsTri-level controlsBi-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: (952) 448-4848 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 (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.

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