(58 days)
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.
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.
This document is a 510(k) summary for the Access Hybritech p2PSA QC, a quality control material intended for monitoring the performance of immunoenzymatic procedures for measuring [-2]proPSA isoform of Prostate Specific Antigen (PSA) using the Access Immunoassay Systems. As such, the information provided focuses on demonstrating substantial equivalence to a predicate device rather than a study proving clinical diagnostic performance against acceptance criteria in the typical sense of a diagnostic medical device.
Therefore, the following answers are tailored to the nature of this submission for a quality control material.
1. Table of Acceptance Criteria and Reported Device Performance
For quality control materials, acceptance criteria typically relate to manufacturing specifications, stability, and reproducibility, ensuring the control itself performs consistently and within expected ranges, rather than diagnostic accuracy against a disease state. The document states: "Based on the results of the product performance characteristics testing, these controls meet product claims and specifications." However, specific numerical acceptance criteria and reported performance values are not detailed in this 510(k) summary. The summary focuses on comparing the new device to a predicate device and asserting that the new device meets specifications, without providing the specific data.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated in this summary) | Reported Device Performance (Summary statement) |
|---|---|---|
| Manufacturing/Product Claims | Consistency across lots, stability (shelf-life), defined control ranges, matrix compatibility, instrument compatibility | "these controls meet product claims and specifications." |
| Reproducibility/Precision | (e.g., Coefficient of Variation % within acceptable limits across runs/instruments) | Not specified, but implied by meeting "product performance characteristics." |
| Stability | (e.g., analyte concentrations remain within specified ranges over shelf-life and in-use period) | "Shelf life: 12 months" (matches predicate), implies stability over this period. "Storage temperature after opening: 2 - 10°C" (matches predicate), implies stability under these conditions. |
2. Sample Size Used for the Test Set and Data Provenance
This is not a study evaluating diagnostic performance on patient samples. Instead, it concerns the performance of a quality control material.
- Sample Size for Test Set: Not applicable in the context of patient data. The "test sets" would be batches or lots of the quality control material itself, evaluated for their consistency and performance on the Access Immunoassay Systems. The number of such lots or runs used for testing is not specified in this summary.
- Data Provenance: Not applicable in the context of patient data origin. The testing would be performed internally by Beckman Coulter, Inc. in a laboratory setting. The data presented is from "product performance characteristics testing," which generally implies internal validation studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. For a quality control material, the "ground truth" is typically established by the manufacturer through rigorous analytical characterization of the control material's components and concentration. It does not involve human expert interpretation of clinical data.
4. Adjudication Method for the Test Set
Not applicable. As described above, the "test set" here refers to the quality control material itself and its performance characteristics, not clinical cases requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
Not applicable. An MRMC study is designed to evaluate the diagnostic performance of a system (human readers, with or without AI assistance) on clinical cases. This submission is for a quality control material, not a diagnostic device or an AI application intended to assist human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a quality control material, not an algorithm. Its function is to monitor the performance of an immunoenzymatic assay system, which itself reports quantitative measurements.
7. The Type of Ground Truth Used
The "ground truth" for a quality control material is its precisely characterized analyte concentration, stability properties, and matrix composition. This "ground truth" is established through analytical methods and manufacturing processes according to defined specifications, not by expert consensus, pathology, or outcomes data in the clinical sense. The document states that "Final concentrations are determined by value assignment using the Access Immunoassay Systems," indicating that the "ground truth" (assigned value) of the control itself is determined by the system it's designed to monitor, in a calibrated manner.
8. The Sample Size for the Training Set
Not applicable. This is for a quality control material, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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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: 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.
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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 aredetermined by value assignmentusing the Access ImmunoassaySystems. | Final concentrations aredetermined by value assignmentusing the Access ImmunoassaySystems. |
| Storage temperature afteropening | 2 - 10°C | 2 - 10°C |
| Instrumentation / technology | Access Immunoassay Systems –Chemiluminescent | Access Immunoassay Systems –Chemiluminescent |
| Shelf life | 12 months | 12 months |
| Manufacturer | Beckman Coulter | Beckman Coulter |
| Control matrix | Buffered bovine serum albumin(BSA) matrix with preservatives. | Buffered bovine serum albumin(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: (952) 448-4848 Internet: www.beckmancoulter.com
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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
§ 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.