← Product Code [GGN](/productcode/GGN) · K052697

# HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL (K052697)

_Akers Biosciences, Inc. · GGN · Jan 4, 2006 · Hematology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K052697

## Device Facts

- **Applicant:** Akers Biosciences, Inc.
- **Product Code:** [GGN](/productcode/GGN.md)
- **Decision Date:** Jan 4, 2006
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.5425
- **Device Class:** Class 2
- **Review Panel:** Hematology

## 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.

## Device Story

The Heparin/Platelet Factor 4 Antibody Serum Panel consists of characterized human serum samples (positive and negative) used as quality control material for the PIFA® Heparin/PF4 Antibody Assay. Samples are sourced from a repository, validated against the GTT® PF4 ENHANCED® ELISA Assay, and packaged in 150 ul vials. Available in 2-member (1 pos/1 neg) or multi-member (6 or 12 member) configurations. Used by laboratory professionals to monitor assay precision, accuracy, and reproducibility, and to identify potential technical errors or reagent failures. The device provides a standardized reference for comparative analysis of test system performance. No preservatives are added; samples are stable through multiple freeze-thaw cycles.

## Clinical Evidence

No clinical data. Bench testing only. Stability and reproducibility studies performed using 6 specimens tested in duplicate over 5 days across multiple freeze-thaw cycles. Results consistently matched expected values on PIFA® Heparin/PF4 Rapid Assay and correlated with GTI® PF4 Enhanced ELISA OD values.

## Technological Characteristics

Serum-based control panel; no preservatives. Two configurations: 2-member or 12-member kits. 150 µl volume per vial. Characterized by GTI® PF4 Enhanced ELISA. Stability validated for multiple freeze-thaw cycles. Professional use only.

## Regulatory 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.

## Special Controls

*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.

## Predicate Devices

- GTT® PF4 ENHANCED® ELISA Assay ([K983379](/device/K983379.md))

## Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
K052697

B. Purpose for Submission:
To obtain clearance for the Heparin/Platelet Factor 4 Antibody Serum Panel controls

C. Measurand:
Heparin PF4 Antibody

D. Type of Test:
Assayed control

E. Applicant:
Akers Biosciences, Inc.

F. Proprietary and Established Names:
Heparin/Platelet Factor 4 Antibody Serum Panel

G. Regulatory Information:
1. Regulation section:
21 CFR 864.5425
2. Classification:
Class II
3. Product code:
GGN
4. Panel:
81 Hematology

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H. Intended Use:

1. Intended use(s):

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.

2. Indication(s) for use:

Assayed controls available for use as a QC panel for routine quality checks or as a qualification panel enabling users to evaluate their PIFA® Heparin PF4 Antibody Assay test systems providing comprehensive data for comparative analysis.

3. Special conditions for use statement(s):

Serum control panel members are identified as positive and negative. These are selected for specific use on the PIFA Heparin PF4 Antibody Assay test.

4. Special instrument requirements:

I. Device Description:

The Heparin/Platelet Factor 4 Antibody Serum Panel is a well-defined 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 GTI® PF4 Enhanced ELISA test. No preservatives are added. Samples are chosen to provide a broad range of reactivity and to include samples with both low and high antibody levels.

Two types of kit configurations are available:

Two-Member QC Panel – consists of one positive and one negative serum each approximately 150 µl in volume. Reagents normally used for routine quality checks and to help identify whether technical errors or reagent failures have occurred.

Multi-Member Qualification Panel – consists of 10 positive and two negative sera each approximately 150 µl in volume. Reagents are normally used for qualifying and evaluating their PIFA® Heparin PF4 Antibody Assay test systems where a broad

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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.

# J. Substantial Equivalence Information:

1. Predicate device name(s):

GTI® PF4® ELISA Assay

2. Predicate 510(k) number(s):

K983379

3. Comparison with predicate:

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Characteristic | Heparin PF4 Antibody Serum Panel | GTI PF4 ENHANCED® ELISA (controls provided with test)  |
|  Test type for control use | Qualitative | Qualitative  |
|  Sample Matrix | Serum | Serum  |
|  Testing Environment | Professional | Professional  |
|  Test Determination for Positive | ≥ 0.40 | ≥ 0.40  |
|  Test Determination for Negative | ≤ 0.40 | ≤ 0.40  |
|  Differences  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Characteristic | Heparin PF4 Antibody Serum Panel | GTI PF4 ENHANCED® ELISA (controls provided with test)  |
|  Indications for Use | Assayed controls available for use as a QC panel for routine quality checks or as a qualification panel enabling users to evaluate their PIFA® Heparin PF4 Antibody Assay test systems providing comprehensive data for comparative analysis. | Assayed controls included with each test. Run to help determine if technical errors or reagent failures have occurred.  |
|  Positive Control Determination Level (OD) | ≥ 0.50 | ≥ 1.80  |

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|  Differences  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  reading) |  |   |
|  Negative Control Determination Level (OD reading) | ≤ 0.32 | ≤ 0.30  |

K. Standard/Guidance Document Referenced (if applicable):

L. Test Principle:

Not applicable

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Precision

Prior to use for testing, a single-use aliquot is thawed in a 37° C water bath. The GTI® PF4® Enhanced ELISA Assay is initially utilized to characterize each serum member.

Five serum samples were tested within the course of a 24-hour period by a single laboratory technician. Each serum sample was tested 10 times on both assays. The PIFA® Heparin/PF4 Rapid Assay provides a qualitative (positive/negative) results that consistently correlates with the O.D. values received when samples were run on the GTI® PF4® ELISA Assay.

GTI® PF4 Enhanced® ELISA Assay

|   | Positive | Negative  |
| --- | --- | --- |
|  PIFA® H/PF4 Rapid Assay Positive | 30 | 0  |
|  Negative | 0 | 20  |

b. Linearity/assay reportable range:

Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

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A stability study and reproducibility study were conducted in conjunction to test the ability of the Heparin/Platelet Factor 4 Antibody Serum Panel to remain stable after a number of freeze-thaw cycles.

Six specimens, each identified with an individual lot number, were utilized for the study covering positive and negative samples. Five vials of each sample were prepared for testing and observed over the course of five days by a single laboratory technician. Initially, all samples (n=30), were stored under deep freeze conditions. On day one of the study, the 30 vials were quick-thawed by submersion into a 37° C water bath.

A single vial of each identified specimen was utilized on a specific testing interval. From a single vial, two aliquots from each of the six specimens were tested on the PIFA® Heparin/PF4 Rapid Assay. After the tests were completed, the vials utilized for the test interval were segregated from those not tested and all vials were flash-frozen. The vials formerly utilized were kept in deep-freeze conditions for the remainder of the study. The same procedure was performed on each test interval period thereafter until the five days were complete. At the end of the five days, all vials were retrieved from deep-freeze conditions, quick-thawed, and utilized in the same manner through testing with the GTI® PF4® Enhanced ELISA Assay.

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® Heparin/PF4 Rapid Assay. In addition, the results consistently correlated with the O.D. values received when samples were run on the GTI® assay, indicating the ability of the serum panel member to remain stable through numerous freeze-thaw cycles. The PIFA® Heparin/PF4 Rapid Assay package insert states that more than one additional freeze-thaw cycle must be validated by the user.

|  GTI® PF4 Enhanced® ELISA Assay  |   |   |
| --- | --- | --- |
|   | Positive | Negative  |
|  PIFA® H/PF4 Rapid Assay Positive | 40 | 0  |
|  Negative | 0 | 20  |

d. Detection limit:

Not applicable

e. Analytical specificity:

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Not applicable

f. Assay cut-off:

Not applicable

2. Comparison studies:

a. Method comparison with predicate device:

Not applicable

b. Matrix comparison:

Not applicable

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable

b. Clinical specificity:

Not applicable

c. Other clinical supportive data (when a. and b. are not applicable):

4. Clinical cut-off:

Not applicable

5. Expected values/Reference range:

The PIFA® Heparin/PF4 Rapid Assay provides a qualitative (positive or negative) result. A “positive” identified serum panel has O.D. values greater than or equal to 0.500 as determined on the GTI® PF4 ELISA Assay. A “negative” identified serum panel has O.D. values less than or equal to 0.320 as determined on the GTI® PF4 ELISA Assay.

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

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O. Conclusion:

1. The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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**Source:** [https://fda-staging.innolitics.com/device/K052697](https://fda-staging.innolitics.com/device/K052697)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com