(170 days)
BK950005, BK 990043
No
The device description details a standard ELISA assay, and there are explicit statements indicating that it is not a machine learning device.
No.
This device is an in vitro diagnostic assay used to detect specific antibodies in patient samples to assist in screening for heparin-induced thrombocytopenia or thrombosis. It does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to be 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".
No
The device is an in vitro diagnostic kit that utilizes a solid phase enzyme linked immunosorbent assay (ELISA), which is a laboratory-based assay involving physical reagents and procedures, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the PF4 IgG™ is "intended to be used as an in vitro diagnostic kit" and is designed to "assist in screening patient samples for the presence of heparin-associated antibodies." This directly aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for diagnosis, treatment, or prevention of disease.
- Device Description: The description details a laboratory assay (ELISA) performed on human serum, which is a specimen from the human body.
- Intended User/Care Setting: The intended users are listed as "hematology, coagulation, or other pathology laboratories," which are typical settings for performing in vitro diagnostic tests.
- Performance Studies: The document includes performance data (Sensitivity, Specificity, Agreement) derived from testing human serum samples, which is standard for demonstrating the analytical and clinical performance of an IVD.
- Predicate Device(s): The mention of predicate devices with K numbers (which are associated with FDA clearances for medical devices, including IVDs) further supports its classification as a medical device, and specifically an IVD given its intended use.
The entire description points to a device designed to be used outside of the human body to analyze a human specimen for diagnostic purposes, which is the core definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
PF4 IgG™ is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies reactive with Platelet Factor 4 (PF4) when it is complexed to polyanionic compounds such as polyvinyl sulfonate (PVS). These antibodies are found in some patients undergoing heparin therapy.
PF4 IgG™ is designed as a solid phase enzyme-linked immunosorbent assay (ELISA). This product is intended to be 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.
PF4 IgG™ is a qualitative screening assay for the detection of heparin associated IgG antibodies in human serum. The presence of heparin associated antibodies are commonly found in patients with Heparin Induced Thrombocytopenia (HIT).
Product codes (comma separated list FDA assigned to the subject device)
LCO
Device Description
The PF4 IgGTM assay is an Enzyme Linked Immunosorbent Assay (ELISA). The PF4 IgG™ ELISA is intended to detect IgG antibodies in human serum that react with Platelet Factor 4 (PF4) when it is complexed to heparin or other polyanionic compounds. The PF4 IgG™ kit contains all of the reagents necessary to perform the assay.
In the PF4 IgG™ assay, patient serum is first diluted (1:4), with the specimen diluent provided in the kit. The diluted sample is then added to microwells to which Platet Factor 4 (PF4) complexed to polyvinyl sulfonate (PVS) has been immobilized. The sample is then incubated for 30 minutes at 37°C. If an antibody which recognizes a site on PF4/PVS complex is present in the patient sample, binding will occur. Following this incubation, a wash step then removes any unbound antibodies. A goat anti-human IgG - alkaline phosphatase conjugate is then added to the wells. The conjugate is incubated for 30 minutes at 37°C. Following this incubation, a wash step then removes any unbound conjugate. The alkaline phosphate substrate, p-nitrophenyl phosphate (pNPP) is then added to the microwells. After a 30 minute incubation at room temperature (22 -- 25°C), the reaction is stopped by addition of the stopping solution (3 M sodium hydroxide). The optical density of the color that develops is measured in a spectrophotometer at 405 or 410 nm using a reference wavelength of 490 nm.
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
hematology, coagulation, or other pathology laboratories
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
Description of Study (Normal Range and Assay Cutoff): One hundred and twenty serum samples were obtained from normal healthy individuals and were tested (in duplicate) in the PF4 IgG™ and the PF4 ENHANCED® assays. The mean of the duplicates was obtained for each sample tested and the results were analyzed for normality of the distribution of the O.D. values.
Description of Study (Comparison of Methods Study): The samples used in the method comparison study consisted of a set of 229 different sera obtained from the BloodCenter of Wisconsin (BCW). Each sample was provided in a single aliquot and was stored frozen at -80°C until the time it was tested. These samples were obtained from patients receiving heparin treatment and were originally tested by the BCW for the presence of PF4/heparin antibodies by the SRA. The SRA is an "in house assay" that detects the presence of antibodies in serum that are capable of activating platelets. The SRA is considered to be the gold standard for testing for antibodies that can cause HIT.
Samples were tested in duplicate in the PF4 IgG™ and PF4 ENHANCED® assays at GTI. The mean of the O.D. values for each sample was obtained. Results were considered to be positive in the PF4 IgG™ and PF4 ENHANCED® assays if the mean of the O.D. value was ≥0.400. Results from the SRA were based on the data provided by the BCW.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Assay Precision: Three samples of varying antibody concentrations were prepared by diluting a patient sample (sera) containing a high level of an anti-PF4/heparin antibody into a pool of normal serum containing no PF4/heparin antibody. This sample was diluted to obtain 3 separate samples that had low positive reactivity (approximately 0.5 O.D. or 0.1 O.D. units above the cutoff), medium positive reactivity, and high positive reactivity. In addition to these samples, the positive and negative controls provided in the kit were used for this study. Each sample or control was tested in duplicate in the PF4 IgGTM assay in 10 separate assays. The calculations of imprecision for the O.D. values showed that the assay demonstrated ≤10% cv total imprecision for samples of all levels of PF4/PVS antibody reactivity. There was 100% agreement between all reportable results (within-run and between-run) for each sample tested.
Normal Range and Assay Cutoff: One hundred and twenty serum samples were obtained from normal healthy individuals and were tested (in duplicate) in the PF4 IgG™ and the PF4 ENHANCED® assays. The normal ranges were calculated to be 0.142 - 0.352 for PF4 IgG™ and 0.332 - 0.407 for PF4 ENHANCED®. The cutoff for the assays was then taken to be the upper end of the normal range (0.352 for PF4 IgG™ and 0.407 for PF4 ENHANCED®). The cutoff of ≥0.400 was confirmed for the PF4 ENHANCED® assay and established for the PF4 IgGTM assay.
Comparison of Methods Study: The samples used in this study consisted of a set of 229 different sera obtained from the BloodCenter of Wisconsin (BCW) from patients receiving heparin treatment and tested by SRA. Samples were tested in duplicate in the PF4 IgG™ and PF4 ENHANCED® assays. The PF4 IgG™ assay showed excellent specificity (co-negativity), and agreement with the predicate device (PF4 ENHANCED®). The PF4 IgG™ assay showed an improved specificity (co-negativity) over the PF4 ENHANCED® assay when compared to the Serotonin Release Assay (SRA).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
| | PF4 IgGTM
Versus SRA | PF4
ENHANCED®
Versus SRA | PF4 IgGTM
versus
PF4
ENHANCED® |
|---------------------------------|-------------------------|--------------------------------|-----------------------------------------|
| Sensitivity (Co-
Positivity) | 100% | 100% | 74% |
| 95% Confidence Interval | 84.5 - 100.0% | 84.5 - 100.0% | 61.0 - 83.4% |
| Specificity (Co-
negativity) | 90% | 83% | 100% |
| 95% Confidence Interval | 85.1 - 93.3% | 77.0 - 87.2% | 97.8 - 100.0% |
| % Agreement | 91% | 84% | 93% |
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.
BK950005, BK 990043
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
DEC 1 9 2007
Image /page/0/Picture/2 description: The image shows the logo for GTI Diagnostics. The logo consists of a stylized image of a person inside of a square. Below the image is the text "GTI. DIAGNOSTICS" in a bold, sans-serif font. The tagline "Good science starts with people." is below the company name.
800 . 233 . 1843 in usa 262 . 754 . 1000 TEL 262 . 754 . 9831 FAX gti@gtidiagnostics.com FMAII gtidiagnostics.com ﻟﻘﺎ ﻳﺪﻳﺮ ﺍﻟﻤﺪﻳﻨﺔ
20925 Crossroads Circle, Suite 200 Waukesha, Wi 53186 USA
510(k) Summary
- I. Submitter:
| Owner's Name: | Genetic Testing Institute, Inc. (GTI) |
|---|---|
| Address: | 20925 Crossroads Circle, Waukesha, WI 53186 |
| Phone: | 262.754.1000 |
| Fax: | 262.754.9831 |
| Name of Contact Person: | Suzette C. Chance, Ph.D. |
| Date Summary Prepared: | June 15, 2007 |
II. Name of Device:
| Device Name: | PF4 IgG™ Solid Phase ELISA |
|---|---|
| Proprietary Name: | PF4 IgG™ |
| Classification Name: | Platelet Factor 4 Radioimmunassay |
| Product Code: | LCO |
III. Name of predicate device for claiming equivalence
GTI-PF4 ENHANCED® (K053559)
IV. Description of Device:
The PF4 IgGTM assay is an Enzyme Linked Immunosorbent Assay (ELISA). The PF4 IgG™ ELISA is intended to detect IgG antibodies in human serum that react with Platelet Factor 4 (PF4) when it is complexed to heparin or other polyanionic compounds. The PF4 IgG™ kit contains all of the reagents necessary to perform the assay.
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Image /page/1/Picture/0 description: The image contains a logo for GTI Diagnostics. The logo features a stylized graphic above the text. Below the company name is the tagline "Good science starts with people."
Antibodies that react with PF4 when it is complexed to heparin are found in some patients undergoing heparin therapy. The presence of these antibodies has been shown to be associated with heparin induced thrombocytopenia Type II (Type II HIT). Heparin Induced Thrombocytopenia (HIT) is an adverse reaction that can occur in patients that are undergoing heparin therapy. HIT occurs in up to 3% of patients that are receiving heparin and can result from treatment with either low molecular weight heparin (LMWH) or unfractionated heparin (UFH). HIT is usually associated with thrombocytopenia and in some cases the more severe complications of arterial or venous thrombosis. The pathophysiology of HIT is linked to the formation of antibodies which are specific for epitopes formed when heparin binds to PF4. These antibodies can subsequently bind to platelets via the FcyRIIa receptor resulting in platelet activation.
It has been previously shown that antibodies which bind to PF4/heparin complexes also bind to PF4 when it is complexed with other polyanionic compounds such as polyvinyl sulfonate (PVS). In the PF4 IgG™ assay, a complex of PF4/PVS, which has been immobilized in the microwells serve as a target for the binding of antibodies associated with Type II HIT.
In the PF4 IgG™ assay, patient serum is first diluted (1:4), with the specimen diluent provided in the kit. The diluted sample is then added to microwells to which Platet Factor 4 (PF4) complexed to polyvinyl sulfonate (PVS) has been immobilized. The sample is then incubated for 30 minutes at 37°C. If an antibody which recognizes a site on PF4/PVS complex is present in the patient sample, binding will occur. Following this incubation, a wash step then removes any unbound antibodies. A goat anti-human IgG - alkaline phosphatase conjugate is then added to the wells. The conjugate is incubated for 30 minutes at 37°C. Following this incubation, a wash step then removes any unbound conjugate. The alkaline phosphate substrate, p-nitrophenyl phosphate (pNPP) is then added to the microwells. After a 30 minute incubation at room temperature (22 -- 25°C), the reaction is stopped by addition of the stopping solution (3 M sodium hydroxide). The optical density of the color that develops is measured in a spectrophotometer at 405 or 410 nm using a reference wavelength of 490 nm.
V. Intended Use
PF4 IgG™ is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect antibodies reactive with Platelet Factor 4 (PF4) when it is complexed to polyanionic compounds such as polyvinyl sulfonate (PVS). These antibodies are found in some patients undergoing heparin therapy.
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VI. Support of substantial equivalence based on comparison of features, characteristics and components to the predicate device:
A comparison of the features and characteristics of the two devices can be summarized as follows:
| PF4 ENHANCED® | PF4 IgGTM | |
|---|---|---|
| Intended Use | PF4 ENHANCED® is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect antibodies reactive with Platelet Factor 4 (PF4) when it is complexed to polyanionic compounds such as polyvinyl sulfonate (PVS). These antibodies are found in some patients undergoing heparin therapy. | PF4 IgGTM is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies reactive with Platelet Factor 4 (PF4) when it is complexed to polyanionic compounds such as polyvinyl sulfonate (PVS). These antibodies are found in some patients undergoing heparin therapy. |
| Indications for Use | PF4 ENHANCED® is designed as a solid phase enzyme-linked immunosorbent assay (ELISA). This product is intended to be 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. | PF4 IgGTM is designed as a solid phase enzyme-linked immunosorbent assay (ELISA). This product is intended to be 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. |
| Technology | ELISA with a colorimetric measurement system | ELISA with a colorimetric measurement system |
| Reportable Results | Qualitative assay; results are | |
| reported as positive or | ||
| negative | Qualitative assay; results are | |
| reported as positive or | ||
| negative | ||
| Packaging Configuration | 13 and 45 Test kits | 13 and 45 Test kits |
| Reagents: | ||
| Microwell strips | Immobilized PF4/PVS | |
| Complex | Immobilized PF4/PVS | |
| Complex | ||
| Concentrated Wash Solution | 10X Tris Buffer, NaCl, | |
| Tween 20, 1% NaN3 | 10X Tris Buffer, NaCl, | |
| Tween 20, 1% NaN3 | ||
| Specimen Diluent | Phosphate Buffered Saline, | |
| 0.05% NaN3 | Phosphate Buffered Saline, | |
| 0.05% NaN3 | ||
| Substrate Buffer | Diethanolamine and | |
| magnesium chloride, 0.02% | ||
| NaN3 | Diethanolamine and | |
| magnesium chloride, 0.02% | ||
| NaN3 | ||
| Substrate | PNPP (crystalline powder) | PNPP (crystalline powder) |
| Stopping Solution | 3 M NaOH | 3 M NaOH |
| Positive Serum Control | Human serum containing | |
| Bovine Albumin and 0.1% | ||
| NaN3 | Human serum containing | |
| Bovine Albumin and 0.1% | ||
| NaN3 | ||
| Negative Serum Control | Human serum containing | |
| 0.1% NaN3 | Human serum containing | |
| 0.1% NaN3 | ||
| Conjugate | Goat anti-human Ig G+A+M | |
| conjugated to alkaline | ||
| phosphatase enzyme | Goat anti-human Ig G | |
| conjugated to alkaline | ||
| phosphatase enzyme |
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The similarities between these two products can be summarized as follows:
- Both PF4 IgG™ and PF4 ENHANCED® have similar intended uses and the same . indications for use
- PF4 IgG™ and PF4 ENHANCED® use the same technology (ELISA) and assay . steps
- . PF4 IgG™ and PF4 ENHANCED® have identical reagents with the exception of the conjugate used for antibody detection
The difference between the two products can be summarized as follows:
The PF4 ENHANCED® kit utilizes a conjugate that detects bound human IgG, IgA, and/or IgM antibodies (goat anti-human IgG+A+M conjugated to alkaline phosphatase). The PF4 IgG™ kit utilizes a conjugate that detects bound human IgG (goat anti-human IgG conjugated to alkaline phosphatase).
VI. Support of substantial equivalence with performance data:
The details of each of the following studies are covered in Section 7: Performance Data of this 510(k). Only a brief summary of these studies is provided in this section.
Assay Precision
Description of Study
Three samples of varying antibody concentrations were prepared by diluting a patient sample (sera) containing a high level of an anti-PF4/heparin antibody into a pool of normal serum containing no PF4/heparin antibody. This sample was diluted to obtain 3 separate samples that had low positive reactivity (approximately 0.5 O.D. or 0.1 O.D. units above the cutoff), medium positive reactivity, and high positive reactivity. In addition to these samples, the positive and negative controls provided in the kit were used for this study. The positive control consists of a human serum containing a PF4/heparin IgG antibody, whereas the negative control consists of a sera sample containing no PF4/heparin antibody.
Each sample or control was tested in duplicate in the PF4 IgGTM assay in 10 separate assavs.
Results and Analysis
To obtain imprecision of the O.D. values, the data were analyzed by ANOVA according to CLSI Document EP-5A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline. In addition, the reportable result (positive or negative) was analyzed for agreement within and between runs according to CLSI Document
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EP 12-A Vol. 22, No 14, User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline.
The calculations of imprecision for the O.D. values showed that the assay demonstrated ≤10% cv total imprecision for samples of all levels of PF4/PVS antibody reactivity. In addition, the correct reportable result was obtained for each result of each assay. There was 100% agreement between all reportable results (within-run and between-run) for each sample tested.
Conclusions
The PF4 IgG™ assay showed acceptable assay imprecision of the O.D. values as well as the reportable results.
Normal Range and Assay Cutoff
Description of Study:
One hundred and twenty serum samples were obtained from normal healthy individuals and were tested (in duplicate) in the PF4 IgG™ and the PF4 ENHANCED® assays. The mean of the duplicates was obtained for each sample tested and the results were analyzed for normality of the distribution of the O.D. values.
Results and Analysis:
The results showed that neither set of data were normally distributed. A nonparametric analysis was used to determine the normal range for each assay. The normal ranges were calculated to be 0.142 - 0.352 for PF4 IgG™ and 0.332 - 0.407 for PF4 ENHANCED®. The calculations were based on a non-parametric 95% reference interval with a 90% confidence. The cutoff for the assays was then taken to be the upper end of the normal range (0.352 for PF4 IgG™ and 0.407 for PF4 ENHANCED®). Calculations for the normal range were performed by GTI's Manager of Clinical and Scientific Affairs (Melissa Pressman, Ph.D.), using the Med Calc software program.
Conclusions:
While statistically different, the upper end of the normal ranges for the PF4 ENHANCED® and the PF4 IgG™ assays were not significantly different. Therefore, the cutoff of ≥0.400 was confirmed for the PF4 ENHANCED® assay and established for the PF4 IgGTM assay.
Comparison of Methods Study
Accuracy was demonstrated by a study in which PF4 IgG™ was compared to both the PF4 ENHANCED® assay and the Serotonin Release Assay (SRA). The following provides a
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description of the study, the results, and conclusions. This study was conducted as an internal study at GTI.
Description of Study:
The samples used in the method comparison study consisted of a set of 229 different sera obtained from the BloodCenter of Wisconsin (BCW). Each sample was provided in a single aliquot and was stored frozen at -80°C until the time it was tested. These samples were obtained from patients receiving heparin treatment and were originally tested by the BCW for the presence of PF4/heparin antibodies by the SRA. The SRA is an "in house assay" that detects the presence of antibodies in serum that are capable of activating platelets. The SRA is considered to be the gold standard for testing for antibodies that can cause HIT.
Samples were tested in duplicate in the PF4 IgG™ and PF4 ENHANCED® assays at GTI. The mean of the O.D. values for each sample was obtained. Results were considered to be positive in the PF4 IgG™ and PF4 ENHANCED® assays if the mean of the O.D. value was ≥0.400. Results from the SRA were based on the data provided by the BCW.
Results and Analysis:
Analysis of the data was performed using 2x2 tables. The PF4 IgG™ assay results were compared to the PF4 ENHANCED® and the SRA. In addition, the PF4 ENHANCED® assay results were compared to those of the SRA. The calculations for co-positivity, conegativity, and % agreement for each comparison are shown in the table below.
| | PF4 IgGTM
Versus SRA | PF4
ENHANCED®
Versus SRA | PF4 IgGTM
versus
PF4
ENHANCED® |
|---------------------------------|-------------------------|--------------------------------|-----------------------------------------|
| Sensitivity (Co-
Positivity) | 100% | 100% | 74% |
| 95% Confidence Interval | 84.5 - 100.0% | 84.5 - 100.0% | 61.0 - 83.4% |
| Specificity (Co-
negativity) | 90% | 83% | 100% |
| 95% Confidence Interval | 85.1 - 93.3% | 77.0 - 87.2% | 97.8 - 100.0% |
| % Agreement | 91% | 84% | 93% |
Conclusions:
The PF4 IgG™ assay showed excellent specificity (co-negativity), and agreement with the predicate device (PF4 ENHANCED®). Although the sensitivity (co-positivity) of the PF4 IgGTM assay compared to the predicate device was only 74%, some of these discordant results could be explained by the fact that some of these samples may contain only IgM and/or IgA antibodies. However, more importantly, the PF4 IgG™ assay showed an improved specificity (co-negativity) over the PF4 ENHANCED® assay when compared to
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the Serotonin Release Assay (SRA). The SRA is considered to be the gold standard for detection of antibodies that result in HIT.
Stability
No additional stability studies were conducted on the PF4 IgG™ kit since this kit consists of reagents that are used in other kits manufactured by GTI for which stability has already been demonstrated. All of the components of PF4 IgGTM kit with the exception of the anti-human IgG conjugate are identical to those of the PF4 ENHANCED® for which stability of each component has already been established. The anti-human IgG conjugate used in the PF4 IgG™ kit is used in other GTI kits for which stability has also been established. These kits have previously cleared by FDA (GTI QuikScreen®; BK950005 and GTI BScreen®; BK 990043). The expiration of the PF4 IgG™ kit is determined by the expiration dating of the component with the least expiration date.
VIII. Conclusion:
Based on comparison with the predicate device, (PF4 ENHANCED®), these data demonstrate that PF4 IgG™ performs comparable to the predicate device and the PF4 IgGTM kit does not present new issues of safety and effectiveness.
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Public Health Service
DEC 1 9 2007
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Genetic Testing Institute C/O Suzette C. Chance 20925 Crossroads Circle Suite 200 Waukesha, Wisconsin 53186-4054
Re: K071781
Trade/Device Name: PF4 IGG Regulation Number: 21 CFR 864.7695 Regulation Name: Platelet Factor 4 Radioimmunassay Regulatory Class: Class II Product Code: LCO Dated: June 15, 2007 Received: July 2, 2007
Dear Ms. Chance:
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
9
Page 2 - Genetic Testing Institute
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 Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert Booker
Robert L. Becker, Jr., M.D., Ph.I Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
10
Indications for Use
510(k) Number (if known): K071781
Device Name: PF4 IgG™
Indications For Use: PF4 IgG™ is a qualitative screening assay for the detection of heparin associated IgG antibodies in human serum. The presence of heparin associated antibodies are commonly found in patients with Heparin Induced Thrombocytopenia (HIT).
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 1
510(k) K071781