(112 days)
Not Found
No
The device description details a manual, qualitative immunoassay based on agglutination and membrane filtration, with no mention of computational analysis, algorithms, or learning processes.
No
This device is an in vitro diagnostic device used for the detection of antibodies, not for therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The HealthTEST® Heparin/Platelet Factor 4 Antibody Assay is an in vitro diagnostic device".
No
The device description clearly outlines physical components: a Mini-reactor device containing a membrane filtration system and a results window, and a dispenser containing reaction reagents. This indicates a hardware-based in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "The HealthTEST® Heparin/Platelet Factor 4 Antibody Assay is an in vitro diagnostic device designed for the detection of antibodies..." This is a clear declaration of its intended use as an IVD.
- Device Description: The description details a test kit that analyzes a biological sample (serum or plasma) to detect specific antibodies. This is characteristic of an in vitro diagnostic test.
- Intended User/Care Setting: It is intended to be used by "hematology, coagulation or other pathology laboratories," which are typical settings for performing in vitro diagnostic tests.
- Performance Studies: The document describes performance studies comparing the device to "commercially available, standard laboratory methods," which is a common practice for evaluating the performance of IVD devices.
The entire description aligns with the definition and characteristics of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HealthTEST® Heparin/Platelet Factor 4 Antibody Assay is an in vitro diagnostic device designed for the detection of antibodies to Platelet Factor 4 complexed to polyanionic compounds such as polystyrene. These antibodies are found in some patients undergoing heparin therapy.
The HEALTHTEST® Heparin/Platelet Factor 4 Antibody Assay is a qualitative in vitro diagnostic device designed for the detection of antibodies to the Platelet Factor 4 complexed to polyanionic compounds such as polystyrene. These antibodies are found in some patients undergoing heparin therapy.
The risk of heparin induced thrombocytopenia (HIT) is greatly increased in patients with recent exposure to heparin. The presence of heparin/PF-4 antibody is associated with patients arisk. for HIT, and is rapidly becoming a standard of care in hematology and cardinlogy. The need for a rapid test to detect these antibodies from serum or plasma in less than 5 minutes is highly desired. This rapid manual assay should be easily performed when STAT results are required,
Product codes (comma separated list FDA assigned to the subject device)
LCO
Device Description
The HealthTEST® Heparin/Platelet Factor 4 Antibody Assay consists of two components: a Mini-reactor device containing a membrane filtration system and a results window, and a dispenser containing reaction reagents.
The Mini-reactor contains a reaction well that allows the sample to react with the reagents. The sample is added to the reaction well followed by the reagents contained in the reagent dispenser. The reagents contain microparticles coated with purified PF-4 protein as well as additional enhancing agents designed to promote rapid agglutination of the particles in the presence of specific antibodies in the test sample.
Once the reagents have reacted with the sample in the reaction well, the reaction mixture automatically collects over the membrane filtration system. This system acts to filter agglutinated particles, while allowing non-agglutinated particles to pass through. Thus, an agglutinated, reactive sample will be trapped within the membrane. Since the dyed particles are trapped by this filter, no particles and hence no color, are able to migrate past the positive/negative line on the results window. Conversely, a nonagglutinated, non-reactive sample will pass through the membrane filter and into the wicking layers, and no color will migrate past the positive/negative line.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Two studies were performed to evaluate the performance of the HealthTEST® Heparin/Platelet Factor 4 Antibody Assay compared to commercially available, standard laboratory methods using fresh samples originating from field sources.
Study #1 Plasma:
Sample size: 175 (23 positive, 152 negative based on ELISA)
HealthTEST Positive: 21 (ELISA Positive), 15 (ELISA Negative)
HealthTEST Negative: 2 (ELISA Positive), 137 (ELISA Negative)
Study #2 Serum:
Sample size: 179 (23 positive, 156 negative based on ELISA)
HealthTEST Positive: 21 (ELISA Positive), 3 (ELISA Negative)
HealthTEST Negative: 2 (ELISA Positive), 153 (ELISA Negative)
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Two non-clinical studies were performed.
Study #1 Plasma:
Specificity = 90.1%
Sensitivity = 91.3%
Overall Agreement = 90.3%
Study #2 Serum:
Specificity = 98.1%
Sensitivity = 91.3%
Overall Agreement = 97.2%
These studies demonstrated that the test is safe and effective for intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Specificity (plasma): 90.1%
Sensitivity (serum & plasma): 91.3%
Specificity (serum): 98.1%
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.
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.
Not Found
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).
Not Found
§ 864.7695 Platelet factor 4 radioimmunoassay.
(a)
Identification. A platelet factor 4 radioimmunoassay is a device used to measure the level of platelet factor 4, a protein released during platelet activation by radioimmunoassay. This device measures platelet activiation, which may indicate a coagulation disorder, such as myocardial infarction or coronary artery disease.(b)
Classification. Class II (performance standards).
0
MAY 2 8 2004
Akers Laboratories, Inc. HealthTEST® Heparin/Platelet Factor 4 Antibody Assay 510(k) Notification
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 K040293.
| 807.92 (a)(1): Name: | Akers Laboratories, 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: | HealthTEST® Heparin/Platelet Factor 4
Antibody Assay |
|-----------------|---------------------------------------------------------|
| Common name: | Platelet Factor 4 Assay |
| Classification: | 21 CFR 864.7695
Product Code: LCO |
807.92 (a)(3): Identification of the legally marketed predicate device
HealthTEST® Heparin/Platelet Factor 4 Antibody Assay is substantially equivelant to the GTI PF4 Elisa Assay, Genetic Testing Institute, Waukesha, WI; K983379
807.92 (a)(4): Device Description
The HealthTEST® Heparin/Platelet Factor 4 Antibody Assay consists of two components: a Mini-reactor device containing a membrane filtration system and a results window, and a dispenser containing reaction reagents.
1
Akers Laboratories, Inc. HealthTEST® Heparin/Platelet Factor 4 Antibody Assay 510(k) Notification
807.92 (a)(4): Device Description (continued)
The Mini-reactor contains a reaction well that allows the sample to react with the reagents. The sample is added to the reaction well followed by the reagents contained in the reagent dispenser. The reagents contain microparticles coated with purified PF-4 protein as well as additional enhancing agents designed to promote rapid agglutination of the particles in the presence of specific antibodies in the test sample.
Once the reagents have reacted with the sample in the reaction well, the reaction mixture automatically collects over the membrane filtration system. This system acts to filter agglutinated particles, while allowing non-agglutinated particles to pass through. Thus, an agglutinated, reactive sample will be trapped within the membrane. Since the dyed particles are trapped by this filter, no particles and hence no color, are able to migrate past the positive/negative line on the results window. Conversely, a nonagglutinated, non-reactive sample will pass through the membrane filter and into the wicking layers, and no color will migrate past the positive/negative line.
807.92 (a)(5): Intended use
The HealthTEST® Heparin/Platelet Factor 4 Antibody Assay is an in vitro diagnostic device designed for the detection of antibodies to Platelet Factor 4 complexed to polyanionic compounds such as polystyrene. These antibodies are found in some patients undergoing heparin therapy.
2
Akers Laboratories, Inc. HealthTEST® Heparin/Platelet Factor 4 Antibody Assay 510(k) Notification
807.92 (a)(6): Technological Similarities and Differences to Predicate
The following chart exhibits similarities and differences between the HealthTEST® Heparin/Platelet Factor 4 Antibody Assay and the GTI PF4 Elisa Assay:
| CHARACTERISTIC | HealthTEST®
Heparin/Platelet Factor 4
Antibody Assay | GTI PF4 ELISA
K983379 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Detects antibodies to the
Heparin/PF4 complex in patient's
circulation | Detects antibodies to the
Heparin/PF4 complex in
patient's circulation |
| Indications for Use | Used as an in vitro diagnostic kit by
hematology, coagulation or other
pathology laboratories to assist in
screening patient samples for the
presence of heparin-associated
antibodies commonly found in
patients with heparin-induced
thrombocytopenia or thrombosis. | Used as an in vitro diagnostic kit
by hematology, coagulation or
other pathology laboratories to
assist in screening patient
samples for the presence of
heparin-associated antibodies
commonly found in patients with
heparin-induced
thrombocytopenia or thrombosis. |
| Assay type | Serology | Serology |
| Sample Matrix | Serum, plasma | Serum |
| Methodology | Immunoassay,
Particulate ImmunoFiltration
Assay (PIFA) | Immunoassay,
Enzyme-linked Immunosorbent
Assay (ELISA) |
| Testing Environment | Professional | Professional |
| Analyte Detection | Antibody to PF-4 complexed with
polyanionic compounds | Antibody to PF-4 complexed
with polyanionic compounds |
| Specificity | 90.1% (plasma)
98.1% (serum) | 89.9% (serum) |
| Sensitivity | 91.3% (serum & plasma) | 95.2% (serum) |
| Throughput | Individual | Batch testing |
| Risk to Patient | Minimal to moderate, interpreted
with other clinical findings | Minimal to moderate, interpreted
with other clinical findings |
The differences in the two testing platforms do not raise new issues of safety and effectiveness.
3
Akers Laboratories, Inc. HealthTEST® Heparin/Platelet Factor 4 Antibody Assay 510(k) Notification
807.92 (b)(1): Brief Description of Non-clinical data
Two studies were performed to evaluate the performance of the HealthTEST® Heparin/Platelet Factor 4 Antibody Assay compared to commercially available, standard laboratory methods using fresh samples originating from field sources.
| Specificity and Sensitivity | |||
|---|---|---|---|
| Study #1 Plasma | ELISA | ||
| Positive | Negative | ||
| HealthTEST Positive | 21 | 15 | |
| Negative | 2 | 137 | |
| Specificity = 90.1% | |||
| Sensitivity = 91.3% | |||
| Overall Agreement = 90.3% | |||
| Study #2 Serum | ELISA | ||
| Positive | Negative | ||
| HealthTEST Positive | 21 | 3 | |
| Negative | 2 | 153 |
Specificity = 98.1% Sensitivity = 91.3% Overall Agreement = 97.2%
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 HealthTEST® Heparin/Platelet Factor 4 Antibody Assay was evaluated for non-clinical and clinical performance characteristics in comprehensive studies. These studies demonstrated that the test is safe and effective for intended use.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 8 2004
Ms. Barbara A. Bagby Director, Quality Assurance & Regulatory Affairs Akers Laboratories, Inc 201 Grove Rd. Thorofare, NJ 08086
Re: K040293
Trade/Device Name: HEALTHTEST® Heparin/Platelet Factor 4 Antibody Assay Regulation Number: 21 CFR 864.7695 Regulation Name: Platelet Factor 4 radioimmunoassay Regulatory Class: Class II Product Code: LCO Dated: April 30, 2004 Received: May 3, 2004
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).
5
Page 2
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 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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Joseph L. Hackett
Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE
510(K) Number (if known): K040293
Device Name: HEALTHTEST® Heparin/Platelet Factor 4 Antibody Assay
Indications for Use:
The HEALTHTEST® Heparin/Platelet Factor 4 Antibody Assay is a qualitative in vitro diagnostic device designed for the detection of antibodies to the Platelet Factor 4 complexed to polyanionic compounds such as polystyrene. These antibodies are found in some patients undergoing heparin therapy.
The risk of heparin induced thrombocytopenia (HIT) is greatly increased in patients with recent exposure to heparin. The presence of heparin/PF-4 antibody is associated with patients arisk. for HIT, and is rapidly becoming a standard of care in hematology and cardinlogy. The need for a rapid test to detect these antibodies from serum or plasma in less than 5 minutes is highly desired. This rapid manual assay should be easily performed when STAT results are required,
Prescription Use L (Part 21 CFR 801 Subpart D)
OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE AS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OD
Division Sign-Off
Page 1 of {
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Ko Yo293