(98 days)
The Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control, intended for use as a serum QC control to monitor and evaluate precision and accuracy of the (qualitative) PIFA® Heparin/PF4 Antibody Assay. Included are both confirmed positive and negative control panel members.
The panel members enable the users to evaluate their PIFA® Heparin/PF4 Antibody Assay test systems and provide comprehensive data for comparative analysis.
The Heparin/Platelet Factor 4 Antibody Serum Panel is a well-qualified serum sample identified as a positive or negative sample against the PIFA® Heparin/Platelet Factor 4 Antibody Assay. The panels are assembled from its repository of frozen serum samples, with reactivity as determined by the (FDA cleared) GTT® PF4 ENHANCED® ELISA Assay test currently available within the United States. No preservatives are added. Samples are chosen to provide a broad range of reactivity and to include samples with low antibody levels and samples with high antibody levels. A "positive" identified serum panel has OD values greater than 0.400 as determined on the GTT® PF4 ENHANCED® ELISA Assay test.
Two types of kit configurations are available, specifically for use on the PIFA ® Heparin/Platelet Factor 4 Antibody Assay test systems: 2 Member QC Panel (1 positive and 1 negative sera) and Multi-Member Qualification Panel (either a 12-Member (10 positive and 2 negative sera) or 6-Member (5 positive and 1 negative sera)). All panel member vials each contain approximately 150 ul in total volume.
Here's an analysis of the acceptance criteria and study information provided for the Heparin/Platelet Factor 4 Antibody Serum Panel:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a numerical or target performance metric for the device itself. Instead, it describes the expected consistent performance of the control panel members when tested with the PIFA® Heparin/Platelet Factor 4 Rapid Assay and correlation with the GTT® PF4 ENHANCED® ELISA Assay. The performance is reported in terms of reproducibility and precision.
Here's a table summarizing the reported device performance in relation to what can be inferred as expected outcomes:
| Performance Metric | Expected Outcome (Implied Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Reproducibility | Consistent expected results with PIFA® assay across freeze-thaw cycles. | PIFA® H/PF4 Rapid Assay vs. GTI® PF4 ENHANCED® Value:Positive: 40 (correctly positive)Negative: 20 (correctly negative)(No false positives or negatives reported) |
| Precision | Consistent expected results with PIFA® assay across multiple formats/runs. | PIFA® H/PF4 Rapid Assay vs. GTI® PF4 ENHANCED® ELISA Assay Value:Positive: 30 (correctly positive)Negative: 20 (correctly negative)(No false positives or negatives reported) |
| Stability (via freeze-thaw) | Maintain characterization (positive/negative) through freeze-thaw cycles. | Panel members consistently produced expected results and correlated with O.D. values from the GTT® PF4 ENHANCED® ELISA assay after varying freeze-thaw cycles. |
| Correlation | Results consistently correlate with O.D. values from the GTT® PF4 ENHANCED® ELISA assay. | Results consistently correlate with the O.D. values from the GTT® PF4 ENHANCED® ELISA assay for both reproducibility and precision studies. |
Note on "Acceptance Criteria": The document focuses more on demonstrating the consistency and stability of the control panels, rather than setting specific quantitative acceptance thresholds for accuracy or sensitivity/specificity of the control panels themselves. The "acceptance" is implied by the consistent and expected categorization (positive/negative) of the control samples.
2. Sample Size Used for the Test Set and Data Provenance
-
Reproducibility Study (Study #1):
- Sample Size: 40 positive samples and 20 negative samples were tested repeatedly. (Total = 60 distinct samples, each tested in duplicate over 5 days through varying freeze-thaw cycles).
- Data Provenance: Not explicitly stated, but the testing was performed "internally" and/or by an "independent laboratory." There is no mention of country of origin of the data. The study design ("repetition of the testing procedure utilizing the PIFA® Heparin/Platelet Factor 4 Rapid Assay in conjunction with the GTT® PF4 ENHANCED® ELISA Assay") suggests a controlled lab setting.
- Retrospective/Prospective: Not explicitly stated, but the studies describe active testing being performed, suggesting a prospective design from the perspective of generating the performance data for the panels. The repository of frozen serum samples from which the panels are assembled would likely be existing (retrospective collection), but the testing itself is prospective.
-
Precision Study (Study #2):
- Sample Size: 30 positive samples and 20 negative samples were tested. (Total = 50 distinct samples, each tested in multiple formats.)
- Data Provenance: Same as Reproducibility Study – "internally" and/or "independent laboratory", no country of origin, likely prospective testing on existing samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth for the test set (the characterization of the control samples as "positive" or "negative") was established using the FDA cleared GTT® PF4 ENHANCED® ELISA Assay.
- Number of Experts: Not applicable in the context of human experts.
- Qualifications of Experts: Not applicable. The ground truth relies on the performance of a previously cleared, predicate assay.
- The document states: "A 'positive' identified serum panel has OD values greater than 0.400 as determined on the GTT® PF4 ENHANCED® ELISA Assay test." This establishes the objective criterion for ground truth.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by an objective assay (GTT® PF4 ENHANCED® ELISA Assay) with a clear optical density (OD) cutoff, not through expert adjudication.
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
Not applicable. This device is an assayed control panel, not an AI diagnostic device that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an algorithm or AI device. It is a physical control panel. The performance described is the standalone performance of the control panel itself when used with the PIFA® Heparin/Platelet Factor 4 Rapid Assay, and its correlation with the predicate GTT® PF4 ENHANCED® ELISA Assay.
7. The Type of Ground Truth Used
The ground truth used for characterizing the control panel members (determining if they are "positive" or "negative") was based on the performance of a predicate, FDA-cleared laboratory assay (GTT® PF4 ENHANCED® ELISA Assay) with objective quantitative cutoff values (OD > 0.400 for positive).
8. The Sample Size for the Training Set
The concept of a "training set" is not directly applicable here in the machine learning sense. The panels are assembled from a repository of frozen serum samples, but the document does not specify the total size of this repository or how many samples were used for "training" in the sense of developing the panel characteristics. The samples chosen for the panels "provide a broad range of reactivity and to include samples with low antibody levels and samples with high antibody levels," implying selection criteria rather than an algorithmic training process.
9. How the Ground Truth for the Training Set Was Established
Similarly to the test set, the characterization of the samples within the repository (and thus, for any "training" or selection process for the panels) would have been established by determining their reactivity using the GTT® PF4 ENHANCED® ELISA Assay. The document states that the reactivity was "as determined by the (FDA cleared) GTT® PF4 ENHANCED® ELISA Assay test."
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Image /page/0/Picture/0 description: The image shows a date written as JAN 4 2006. The month is JAN, the day is 4, and the year is 2006. The text is written in a bold, sans-serif font.
Image /page/0/Picture/1 description: The image shows the logo for Akers Biosciences. The logo features a stylized letter A inside of a circle on the left. To the right of the logo is the text "Akers Biosciences" in a bold, sans-serif font. Below the company name is the tagline "Accelerating Diagnostic Science To Deliver Real-Time Results" in a smaller font.
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.
The assigned 510(k) number is K052697.
| 807.92 (a)(1): Name: | Akers Biosciences, Inc. |
|---|---|
| Address: | 201 Grove Road |
| Thorofare, NJ 08086 | |
| Phone: | (856) 848-8698 |
| FAX: | (856) 848-0269 |
| Contact: | Barbara A. Bagby |
807.92 (a)(2): Device Name – trade name and common name, and classification
| Trade name: | Heparin/Platelet Factor 4 Antibody Serum Panel |
|---|---|
| Common name: | Plasma, Coagulation Control |
| Classification: | 21 CFR 864.5425Product Code: GGN |
807.92 (a)(3): Identification of the legally marketed predicate device
Heparin/Platelet Factor 4 Antibody Serum Panel is substantially equivalent to the controls provided in the GTT® PF4 ENHANCED® ELISA Assay manufactured by Genetic Testing Institute, Waukesha, WI; K983379
807.92 (a)(4): Product Description
The Heparin/Platelet Factor 4 Antibody Serum Panel is a well-qualified serum sample identified as a positive or negative sample against the PIFA® Heparin/Platelet Factor 4 Antibody Assay.
Attachment #2
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Akers Biosciences, Inc. Heparin/Platelet Factor 4 Antibody Serum Panel 510(k) Notification
Section 7, 510(k) Summary (continued)
The panels are assembled from its repository of frozen serum samples, with reactivity as determined by the (FDA cleared) GTT® PF4 ENHANCED® ELISA Assay test currently available within the United States. No preservatives are added. Samples are chosen to provide a broad range of reactivity and to include samples with low antibody levels and samples with high antibody levels. A "positive" identified serum panel has OD values greater than 0.400 as determined on the GTT® PF4 ENHANCED® ELISA Assay test.
Two types of kit configurations are available, specifically for use on the PIFA ® Heparin/Platelet Factor 4 Antibody Assay test systems:
2 Member QC Panel
This panel consists of 1 positive and 1 negative sera each approximately 150 ul in total volume. These are normally used for routine quality checks and to help determine if technical errors or reagent failures have occurred.
Multi-Member Qualification Panel
This panel consists of either a 12-Member (10 positive and 2 negative sera) or 6-Member (5 positive and 1 negative sera). All panel member vials each contain approximately 150 ul in total volume. These are normally used for qualifying and evaluating PIFA® Heparin PF4 Antibody Assay test systems where a broad range of reactivity levels is desired. They provide comprehensive data for comparative analysis in regard to sensitivity, specificity, reproducibility, and lot-to-lot variability.
Data for comparative values on all panel members are available for reference only.
807.92 (a)(5): Intended use
The Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control, intended for use as a serum QC control to monitor and evaluate precision and accuracy of the (qualitative) PIFA® Heparin/PF4 Antibody Assay. Included are both confirmed positive and negative control panel members.
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Akers Biosciences, Inc. Heparin/Platelet Factor 4 Antibody Serum Panel 510(k) Notification
Section 7, 510(k) Summary (continued)
807.92 (a)(5): Intended use (continued)
The panel members enable the users to evaluate their PIF A® Heparin/PF4 Antibody Assay test systems and provide comprehensive data for comparative analysis.
807.92 (a)(6): Technological Similarities and Differences to Predicate
The following chart exhibits similarities and differences between the Heparin/Platelet Factor 4 Antibody Serum Panel (controls) and the controls provided with test GTI® PF4 ENHANCED® ELISA distributed by Genetic Testing Institute with their test.
| CHARACTERISTIC | Heparin/Platelet Factor 4Antibody Serum PanelK040293 | GTI® PF4 ENHANCED®ELISA(controls provided with test)K983379 |
|---|---|---|
| Indications for Use | Assayed controls available for useas a QC panel for routine qualitychecks or as a qualification panelenabling users to evaluate theirPIFA® Heparin PF4 AntibodyAssay tests systems providingcomprehensive data forcomparative analysis. | Assayed controls included witheach test. Run to help determineif technical errors or reagentfailures have occurred. |
| Test which controls areused | Qualitative | Qualitative |
| Sample Matrix | Serum | Serum |
| Testing Environment | Professional | Professional |
| Positive ControlDetermination Level(OD reading) | ≥0.50 | ≥1.80 |
| Negative ControlDetermination Level(OD reading) | ≤0.32 | ≤0.30 |
| Test Determination forPositive | ≥0.40 | ≥0.40 |
| Test Determination forNegative | ≤0.40 | ≤0.40 |
The differences in the two testing platforms do not raise new issues of safety and effectiveness.
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Akers Biosciences. Inc. Heparin/Platelet Factor 4 Antibody Serum Panel 510(k) Notification
Section 7, 510(k) Summary (continued)
807.92 (b)(1): Brief Description of Non-clinical data
Studies were performed to evaluate the performance of the Heparin/Platelet Factor 4 Antibody Serum Panels for reproducibility (stability, including freeze-thaw), and precision.
Study #1 was performed to test the reproducibility of the Heparin/Platelet Factor 4 Antibody Serum Panel through repetition of the testing procedure utilizing the PIFA® Heparin/Platelet Factor 4 Rapid Assay in conjunction with the GTT® PF4 ENHANCED® ELISA Assay. This study also provided data supporting the ability of the Heparin/Platelet Factor 4 Antibody Serum Panel to remain stable after a number of freeze thaw cycles to mimic panel member handling conditions when utilized in the field. Included in the study were "borderline" samples that are near the cutoff range for positive and/or negative.
From testing each of the characterized samples in duplicate over a period of five days through a varying number of freeze-thaw cycles, the Heparin/Platelet Factor 4 Antibody Serum Panel consistently produced expected results from the PIFA® assay. In addition, the results consistently correlate with the O.D. values received when samples were run on the GTT® PF4 ENHANCED® ELISA assay, indicating the ability of the serum panel member to remain stable through numerous freeze-thaw cycles.
Reproducibility
GTI® PF4 ENHANCED® Value (pos/neg)
| Positive | Negative | ||
|---|---|---|---|
| PIFA ® H/PF4 Rapid Assay | Positive | 40 | 0 |
| Negative | 0 | 20 |
Study #2 was conducted to support the quality of the serum panel members processed for use with the PIFA® Heparin/Platelet Factor 4 Rapid Assay. Included in the study were "borderline" samples that are near the cutoff range for positive and/or negative.
Page 30
Attachment #2
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Akers Biosciences. Inc. Heparin/Platelet Factor 4 Antibody Serum Panel 510(k) Notification
Section 7, 510(k) Summary (continued)
807.92 (b)(1): Brief Description of Non-clinical data (continued)
From testing each of the characterized samples in multiple format and consistently receiving the expected results from the PIFA® assay, the data reflects the precision provided by the assay. In addition, the results consistently correlate with the O.D. values received when samples were run on the GTT® PF4 ENHANCED® ELISA assay, illustrating the ability of the serum panel member to deliver appropriate results through multiple testing procedures.
Precision
GTI® PF4 ENHANCED® ELISA Assay Value (pos/neg)
| Positive | Negative | ||
|---|---|---|---|
| PIFA ® H/PF4 Rapid Assay | Positive | 30 | 0 |
| Negative | 0 | 20 |
807.92 (b)(2): Brief Description of Clinical Data
Not applicable, all testing performed via bench by independent laboratory and/or internally.
807.92 (b)(3): Conclusions from Non-clinical and Clinical Testing
The Heparin/Platelet Factor 4 Antibody Serum Panel values were evaluated for non-clinical and performance characteristics (precision and reproducibility) in comprehensive studies. These studies demonstrated that the test is safe and effective for intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Barbara A. Bagby Director, Regulatory Affairs Akers Biosciences, Inc. 201 Grove Road Thorofare, NJ 08086
Re: K052697 Trade/Device Name: Heparin/Platelet Factor 4 Antibody Serum Panel Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: GGN Dated: November 23, 2005
JAN 4
2006
Received: November 30, 2005
Dear Ms. Bagby:
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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
lobatz Beckerh
Robert L. Becker, Jr., MD, PHD Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Akers Biosciences, Inc. Heparin/Platelet Factor 4 Antibody Serum Panel 510(k) Notification
STATEMENT OF INTENDED USE
510(k) Number (if Known):
Device Name:
Heparin/Platelet Factor 4 Antibody Serum Panel
Indications for Use:
The Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control, intended for use as a serum QC control to monitor and evaluate precision and accuracy of the (qualitative) PIFA® Heparin PF4 Antibody Assay. Included are both confirmed positive and negative control panel members.
The panel members enable the users to evaluate their PIFA® Heparin PF4 Antibody Assay test systems and provide comprehensive data for comparative analysis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 7
Prescription Use X
(Per 21 CRF 801.109)
OR
Over-the-Counter Use - - -(Optional Format 1-2-96)
Robert Becker
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k 052697
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.