(31 days)
Not Found
No
The device is an ELISA assay and the summary explicitly states it is not an AI/ML device.
No
This device is an in vitro diagnostic assay used for screening purposes to detect antibodies associated with Heparin Induced Thrombocytopenia (HIT). It does not directly treat or prevent a disease, which is the definition of a therapeutic device.
Yes
Explanation: The device is described as a "qualitative screening assay for the detection of heparin associated IgG antibodies" used to identify the presence of antibodies commonly found in patients with Heparin Induced Thrombocytopenia (HIT). This information is used for diagnosis.
No
The device is an in vitro diagnostic (IVD) assay kit (ELISA) containing reagents, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "detection of heparin associated IgG antibodies in human serum or plasma." This involves testing biological samples (serum or plasma) in vitro (outside the body) to provide information about a patient's health status (presence of antibodies associated with HIT).
- Device Description: The description details an "enzyme linked immunosorbent assay (ELISA)," which is a common laboratory technique used for in vitro diagnostic testing. It also mentions the kit contains "all of the reagents necessary to perform the assay," indicating it's a self-contained system for in vitro analysis.
- Sample Type: The assay uses "human serum or plasma," which are biological specimens collected from a patient for in vitro analysis.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PF4 IgG assay is a qualitative screening assay for the detection of heparin associated IgG antibodies in human serum or plasma. The presence of heparin-associated antibodies are commonly found in patients with Heparin Induced Thrombocytopenia (HIT).
Product codes
LCO
Device Description
PF4 IgG assay is an enzyme linked immunosorbent assay (ELISA). The PF4 IgG ELISA is intended to detect IgG antibodies in human serum or plasma 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.
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 is now known 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.
Test Procedure: Patient sample is added to microwells coated with platelet factor 4 (PF4) complexed to polyvinyl sulfonate (PVS). If an antibody recognizing a site on PF4:PVS is present, binding will occur. Unbound antibodies are then washed away. An alkaline phosphatase labeled anti-human globulin reagent (Anti-IgG) is added to the wells and incubated. The unbound Anti-IgG is washed away and the substrate PNPP (p-nitrophenyl phosphate) is added. After a 30-minute incubation period, the reaction is stopped with Stopping Solution. The optical density of the color that develops is measured in a spectrophotometer.
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
Prescription Use
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
Not Found
Summary of Performance Studies
Process Validation (Modification, Positive Serum Control Raw Material Change): Three validation batches of PF4 Positive Serum Control were manufactured. All acceptance criteria were met.
Precision Study (Modification, Positive Serum Control Raw Material Change): Testing was performed by 3 operators, five assays were conducted by each. Single lot of PF4 IgG kit used. Three validation lots of Positive Serum Control tested concurrently on each of the 5 assays (days). All results met IFU acceptance criteria and were 100% positive, demonstrating 100% agreement within run and between run. All pre-defined Acceptance Criteria were met.
Comparison of Serum and Plasma (ACD or Sodium Citrate) Sample Types: An internal study was conducted using 174 frozen serum and plasma samples from Florida Hospital. 98.85% Agreement (172/174) was met between qualitative results obtained with serum and plasma. Linear regression comparing OD values showed very good correlation (R2 = 99.3%). Slope = 0.9476 and intercept = -0.009914. Equivalent results obtained for both sample types.
Comparison of ACD and Sodium Citrate (plasma) to Serum: Blood from 24 individuals known to be PF4:heparin antibody negative was collected in ACD, Serum, or Sodium Citrate tubes. High level reacting anti-PF4 heparin antibody sample used for spiking study (1:100 medium positive, 1:1000 low positive). All samples tested gave equivalent results to serum samples.
Lot to Lot Comparison (Modification, Stopping Solution Change): Three lots of ESS (new stopping solution) were manufactured and tested against 3M NaOH (predicate stopping solution). All acceptance criteria were met.
Process Validation (Modification, Stopping Solution Change): Three lots of the new Stopping Solution (ESS) manufactured and tested with PF4 IgG assay. Well-to-well variation and expected qualitative results evaluated. All wells met acceptance criteria for well-to-well variation. For qualitative results, finished product QC panel tested with all four lots of Stopping Solution: All 21 positive samples and 24 negative samples met their expected qualitative result on all three lots of new Stopping Solution and one lot of 3M NaOH Stopping Solution. All assays met QC requirements in the IFU.
Shelf Life: PF4 IgG assay has a shelf life of 24 months, supported by stability studies. All acceptance criteria were met.
Key Metrics
98.85% Agreement (172/174) was met between the qualitative results obtained with serum and plasma.
R2 = 99.3% correlation between OD values for serum and plasma.
Slope = 0.9476 and intercept = -0.009914 for regression analysis of plasma versus serum OD values.
Predicate Device(s)
PF4 IgG (K071781)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
June 18, 2020
Immucor GTI Diagnostics, Inc. Allison Stray Sr. Director QA/RA 20925 Crossroads Circle Waukesha, Wisconsin 53185
Re: K201311
Trade/Device Name: PF4 IgG assay Regulation Number: 21 CFR 864.7695 Regulation Name: Platelet Factor 4 Radioimmunoassay Regulatory Class: Class II Product Code: LCO Dated: May 15, 2020 Received: May 18, 2020
Dear Allison Stray:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
1
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Takeesha Taylor-Bell Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name PF4 IgG
Indications for Use (Describe)
PF4 IgG assay is a qualitative screening assay for the detection of heparin associated IgG antibodies in human serum or plasma. The presence of heparin-associated antibodies are commonly found in patients with Heparin Induced Thrombocytopenia (HIT).
IVD
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the word "IMMUCOR." in large purple font. Above the word is a curved line that is colored with a gradient from red to blue. The word is the logo for the company Immucor, which provides transfusion and transplantation diagnostic products.
Section 5.0 510(k) Summary
| 1. Submitter | |
|---|---|
| Owner's Name: | Immucor GTI Diagnostics, Inc. |
| Address: | 20925 Crossroads Circle, Waukesha, WI 53186 |
| Phone: | (262) 754-1000 |
| Fax: | (262) 754-9831 |
| Establishment Registration Number: | 2183608 |
| Name of Contact Person: | Allison Stray (astray@immucor.com) |
| Date Summary Prepared: | May 15, 2020 |
| 2. Name of Device | |
| Device Name: | PF4/PVS Complex IgG Antibody Detection Assay |
| Proprietary Name: | PF4 IgG |
| Common Name: | Platelet Factor 4 Assay |
| Regulation Number: | 21CFR 864.7695 |
| Classification: | Class II |
| Product Code: | LCO |
| Establishment Registration Number: | 2183608 |
-
- Name of Predicate Device for Claiming Equivalence PF4 IgG (K071781)
4. Description of Device
PF4 IgG assay is an enzyme linked immunosorbent assay (ELISA). The PF4 IgG ELISA is intended to detect IgG antibodies in human serum or plasma 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.
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 is now known 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.
Test Procedure
Patient sample is added to microwells coated with platelet factor 4 (PF4) complexed to polyvinyl sulfonate (PVS). If an antibody recognizing a site on PF4:PVS is present, binding will occur. Unbound antibodies are then washed away. An alkaline phosphatase labeled anti-human globulin reagent (Anti-IgG) is added to the wells and incubated. The unbound Anti-IgG is washed away and the substrate PNPP (p-nitrophenyl phosphate) is added. After a 30-minute incubation period, the reaction is stopped with Stopping Solution. The optical density of the color that develops is measured in a spectrophotometer.
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Image /page/4/Picture/0 description: The image shows the logo for Immucor. The logo consists of the word "IMMUCOR" in purple, with a multicolored arc above it. The arc is red on the left, transitioning to orange, yellow, green, and blue on the right. The logo is simple and modern.
Engineering drawings or schematics are not applicable to the PF4 IgG Assay. The device consists of reagents and drawings are not pertinent to describe the device.
5. Intended Use
PF4 IgG is a qualitative screening assay for the detection of heparin associated IgG antibodies in human serum or plasma.
6. Substantial Equivalence
This Special 510(k) is for a Positive Serum Control raw material change and other changes the prior company did not file. The Positive Serum Control raw material modification in this submission is from human serum containing Bovine Albumin and 0.1% NaN3 to human serum containing Bovine Albumin and 0.1% NaN3 plus a chimeric (mouse Fab/Human Fc) monoclonal antibody in the PF4 IgG positive control reagent.
The modification of the PF4 IgG and need for this submission is due to supply of the predicate PF4 IgG positive control material. The current supply of the PF4 IgG positive control material is depleting and will not be available in the future.
Two (2) additional changes, the prior company, did not file are being included. Those changes include: 1) Addition of plasma as a sample type, 2) Stopping Solution changed from 3M NaOH to a buffered EDTA solution. The prior company did document a 510(k) Letter to File for both the sample type change and Stopping Solution change. Their rationale for not filing with the Food and Drug Administration included the changes did not have any significant impact to the safety or effectiveness of the device.
There were no design or functionality changes. All elements of the Design History File (DHF) for the proposed device were used as possible and design outputs were created for the proposed device.
The Similarities between the Predicate and Candidate Device:
- The intended use has not changed ●
- The indications for use have not changed .
- The technology (ELISA) and assay steps have not changed ●
- . Reportable results have not changed
- . The packaging configuration has not changed
- . There are no design or functionality changes between the predicate and candidate device
- All reagents are identical with the exception of the Positive Serum Control and the Stopping ● Solution
The Differences between the Predicate and Candidate Device:
- The predicate device only allowed for Serum as the specimen collection type. The candidate ● device allows for without anticoagulant (Serum) and ACD or Sodium Citrate (Plasma) as the specimen collection type.
- The formulation of the Stopping Solution for PF4 IgG is different than the predicate device. . The PF4 IgG Stopping Solution is a buffered EDTA solution which is ready for use, whereas the predicate device utilizes 3M NaOH.
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Image /page/5/Picture/0 description: The image shows the word "IMMUCOR" in large, bold, purple letters. Above the word is a curved line that transitions from purple to red to orange to yellow to green to blue. The word "IMMUCOR" is the main focus of the image.
- . The candidate device contains Positive Serum Control as Human serum containing Bovine Albumin and 0.1% NaN3. The predicate device contains Positive Serum Control as Human serum containing Bovine Albumin and 0.1% NaNy plus chimeric (mouse Fab/Human Fc) monoclonal antibody.
- The candidate device has changes to the IFU as a result of the specimen collection type change and Stopping Solution type change. ●
| The table below provides the comparison between the current version of PF4 IgG and the proposed device. | ||
|---|---|---|
| # | Features /
Characteristics | Predicate Device | Candidate Device | Comments |
|---|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended Use | PF4 IgG is a qualitative screening assay for the
detection of heparin associated IgG antibodies in
human serum. | PF4 IgG is a qualitative screening assay for
the detection of heparin associated IgG
antibodies in human serum or plasma. | The intended use of
the qualitative assay to
detect IgG antibodies
has not changed.
The revised verbiage
adds plasma as a
specimen type. |
| 2 | 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). | PF4 IgG is a qualitative screening assay for
the detection of heparin associated IgG
antibodies in human serum or plasma. The
presence of heparin-associated antibodies are
commonly found in patients with Heparin
Induced Thrombocytopenia (HIT). | N/A |
| 3 | Technology | ELISA with a colorimetric measurement system | Same | N/A |
| 4 | Specimen Collection | Serum | Without anticoagulant (Serum) and ACD or
Sodium Citrate (Plasma) | Prior company made
this change in 2010 |
| 5 | Reportable Results | Qualitative assay; results are reported as positive or
negative | Same | N/A |
| 6 | Packaging
Configuration | 13 and 45 Test kits | Same | N/A |
| # | Features /
Characteristics | Predicate Device | Candidate Device | Comments |
| 7 | Reagents | | | |
| | Microwell Strips | Immobilized PF4/PVS Complex | Same | N/A |
| | Concentrated Wash
Solution | 10X Tris Buffer, NaCl, Tween 20, 1% NaN3 | Same | N/A |
| | Specimen Diluent | Phosphate Buffered Saline, 0.05% NaN3 | Same | N/A |
| | Substrate Buffer | Diethanolamine and magnesium chloride, 0.02% NaN3 | Same | N/A |
| | Substrate | PNPP (crystalline powder) | Same | N/A |
| | Stopping Solution | 3 M NaOH | Buffered EDTA Solution | Prior company made this change in 2010 |
| | Positive Serum
Control | Human serum containing Bovine Albumin and 0.1% NaN3 | Human serum containing Bovine Albumin and 0.1% NaN3 plus
Chimeric (mouse Fab/Human Fc) monoclonal antibody | N/A |
| | Negative Serum
Control | Human serum containing 0.1% NaN3 | Same | N/A |
| | Conjugate | Goat anti-human IgG conjugated to alkaline phosphatase enzyme | Same | N/A |
| 8 | Instructions for Use
(IFU) | PF4 IgG Direction Insert | No changes to the IFU for the Positive Control Serum raw material modification.
IFU changes for the addition of plasma, new Stopping Solution and minor changes are included in Section 13.0, Proposed Labeling. | N/A |
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Image /page/6/Picture/0 description: The image shows the logo for Immucor. The logo is purple and has a rainbow-colored arc above it. The text is in all caps and has a period after the R.
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Image /page/7/Picture/0 description: The image shows the logo for IMMUCOR. The logo consists of the word "IMMUCOR" in purple, with a rainbow-colored arc above it. The arc starts with red on the left and transitions to blue on the right. The logo is simple and modern, and the colors are eye-catching.
7. Company Name Change
Genetic Testing Institute Inc. was purchased by Gen-Probe Inc. in December 2010 and the company name was changed to Gen-Probe GTI Diagnostics, Inc. Immucor purchased Gen-Probe GTI Diagnostics Inc. in March 2013. The company name was subsequently changed to Immucor GTI Diagnostics, Inc.
8. Non-Clinical Studies Supporting Safety and Effectiveness of the Candidate Device
The details of each of the following studies are covered in Sections 14.0 (Sterilization and Shelf Life) and 18.0 (Performance Testing Bench). Only a brief summary of these studies is provided in this section. The manufacturing facility is in conformance with the design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.
8.1 Modification, Positive Serum Control Raw Material Change
Process Validation
Three validation batches of PF4 Positive Serum Control were manufactured for this process validation.
The three validation batches were tested per the PF4 IgG Instructions For Use (IFU-303290.IFUEN, Rev. E) and all acceptance criteria were met.
Based upon the data generated, the PF4 Positive Serum Control manufacturing process consistently delivers product meeting established acceptance criteria and is acceptable for use in the production of the PF4 IgG assay.
Precision Study
Testing was performed by 3 operators and five assays were conducted by each operator.
Testing was completed using a single lot of the PF4 IgG kit. Each of the three validation lots of the Positive Serum Control were tested concurrently on each of the 5 assays (days).
All results met the IFU acceptance criteria and were 100% positive, demonstrating 100% agreement within run and between run. All pre-defined Acceptance Criteria were met.
8.2 Modification, Addition of Plasma as a Sample Type
Comparison of Serum and Plasma (ACD or Sodium Citrate) Sample Types
Samples were obtained from Florida Hospital to perform an internal study. 174 frozen serum and plasma samples were used for the study and testing was performed according to the PF4 IgG Instructions For Use.
98.85% Agreement (172/174) was met between the qualitative results obtained with serum and plasma. A linear regression was performed comparing the OD values obtained from serum and ACD or Sodium Citrate (plasma) samples for PF4 IgG. The regression analysis of plasma versus serum for the PF4 IgG assay demonstrated very good correlation between OD values (R2 = 99.3%). In addition, there was very good agreement between the OD values (slope =0.9476 and intercept = -0.009914).
Equivalent results using serum or plasma (ACD or Sodium Citrate) were obtained in the PF4 IgG assay. Both sample types are acceptable for use in the PF4 IgG assay.
Comparison of ACD and Sodium Citrate (plasma) to Serum
The objective of the internal study was to demonstrate plasma samples collected in ACD or Sodium Citrate give equivalent results to serum.
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Image /page/8/Picture/0 description: The image shows the word "IMMUCOR" in large, purple, sans-serif font. Above the word is a curved line that transitions from red to orange to yellow to green to blue to purple. The word "IMMUCOR" is a company name.
Blood was collected from 24 individuals known to be PF4: heparin antibody negative in ACD (yellow top), Serum (red top) or Sodium Citrate (blue top) tubes. The serum or plasma were separated and equal volume aliquots of each were prepared.
A high level reacting anti:PF4 heparin antibody sample was used for the spiking study. A dilution (1:100) intended to give a medium positive result and a dilution (1:1000) intended to give a low positive result were chosen. The samples were also run without spiking to ensure each sample showed negative reactivity.
The results for all samples tested gave equivalent results to the serum samples. The use of ACD or Sodium Citrate (plasma) samples in the PF4 IgG assay gives equivalent results to those of serum samples.
8.3 Modification, Stopping Solution Change
Lot to Lot Comparison
A lot to lot comparison study was performed to demonstrate the new Stopping Solution (ESS) performs equivalent to the predicate Stopping Solution (3 M NaOH) meeting established acceptance criteria.
Three lots of ESS (referred to as the test solution) were manufactured according to SOP-292 and tested per QAP-017A. The predicate Stopping Solution, 3 M NaOH, was used as a reference in the study.
All acceptance criteria were met demonstrating the new Stopping Solution (ESS) is acceptable to use in the PF4 IgG assay.
Process Validation
Three lots of the new Stopping Solution (ESS) were manufactured according to SOP-292 and tested with the PF4 IgG assay according to the IFU.
Well-to-well variation and expected qualitative results were evaluated to determine if the new Stopping Solution (ESS) was equivalent to the predicate 3 M NaOH Stopping Solution. The predicate Stopping Solution, 3 M NaOH, was used as the reference in the study.
For Well-to-well variation, all wells met acceptance criteria. For qualitative results, the finished product QC panel was tested with all four lots of Stopping Solution. All 21 positive samples and 24 negative samples met their expected qualitative result on all three lots of the new Stopping Solution and the one lot of 3M NaOH Stopping Solution. All assays met the QC requirements in the IFU.
The data demonstrate the new Stopping Solution (ESS) can be used in the PF4 IgG assay.
8.4 Shelf Life
The PF4 IgG assay has a shelf life of 24 months. See Section 14.0, Sterilization and Shelf Life for stability studies performed to support this premarket submission. All acceptance criteria were met.
Conclusion
Based on the non-clinical performance and stability studies, the data demonstrate the modifications to the PF4 IgG device does not present new issues of safety and effectiveness.