(126 days)
Not Found
No
The summary describes a standard ELISA kit for detecting antibodies and does not mention any AI or ML components.
No.
The device is an in vitro diagnostics kit intended for screening patients for antibodies, not for treating a condition.
Yes
The device is described as an "in vitro diagnostics kit" intended to "assist in screening patients samples for the presence of heparin-associated antibodies" which are "commonly found in patients with heparin induced thrombocytopenia or thrombosis (HIT)". These phrases indicate that the device is used to diagnose a medical condition.
No
The device is described as a solid phase enzyme-linked immunosorbent assay (ELISA) kit, which is a laboratory test method involving physical reagents and procedures, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the kits are "intended to be used as an in vitro diagnostics kit."
- Device Description: It describes a test designed to detect antibodies in patient samples, which is a common characteristic of IVD devices.
- Intended User/Care Setting: The intended users are "Hematology, coagulation or other pathology laboratories," which are typical settings for performing in vitro diagnostic tests.
- Summary of Performance Studies: The document details performance studies comparing the device to predicate devices and reference methods, which are standard requirements for demonstrating the performance of IVD devices.
- Key Metrics: The metrics listed (Agreement, Co-positivity, Co-negativity, % Matching, CV) are relevant to evaluating the performance of diagnostic tests.
- Predicate Device(s): The mention of predicate devices (other IVDs) further confirms the device's classification as an IVD.
All of these elements strongly indicate that the ZYMUTEST HIA IgG and IgGAM kits are intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
ZYMUTEST HIA IgG and IgGAM kits are designed as a solid phase enzyme- linked immunosorbent assay (ELISA). These products are intended to be used as an in vitro diagnostics kit by Hematology, coagulation or other pathology laboratories to assist in screening patients samples for the presence of heparin- associated antibodies commonly found in patients with heparin induced thrombocytopenia or thrombosis (HIT).
Product codes (comma separated list FDA assigned to the subject device)
LCO
Device Description
The ZYMUTEST HIA is solid phase enzyme linked immunosorbent assay (ELISA) designed to detect antibodies. These antibodies are found in some patients undergoing heparin therapy.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Inter-lot reproducibility and comparison with predicate device
- Zymutest IgGAM was compared with Asserachrom (predicate device). Total of 44 plasma samples were analyzed. This was an internal study. Positive: Asserachrom 28, Zymutest IgGAM 30, %Agreement 93%. Negative: Asserachrom 16, Zymutest IgGAM 14, %Agreement 88%.
- In clinical studies, Zymutest IgGAM was compared with Asserachrom for n=243 plasma samples. Combined Site 1 & 2: Zymutest Positive 48 (Asserachrom Positive), 32 (Asserachrom Negative). IgGAM Negative 27 (Asserachrom Positive), 136 (Asserachrom Negative). Agreement 76%. Co-positivity 64%. Co-negativity 81%.
- In clinical studies, Zymutest IgGAM was compared with GTI PF4 Enhanced for n=345 plasma samples. Combined Sites 1,2,3: Zymutest IgGAM Positive 101 (GTI PF4-Enhanced Positive), 17 (GTI PF4-Enhanced Negative). Zymutest IgGAM Negative 74 (GTI PF4-Enhanced Positive), 153 (GTI PF4-Enhanced Negative). Agreement 74%. Co-positivity 58%. Co-negativity 90%.
- In clinical studies, Zymutest IgG was compared with Seritonin Release Assay (SRA) for n=174 samples. Matches indicate that both were positive or both were negative.
- In clinical studies, Zymutest IgG was compared with Asserachrom for n=243 samples. Combined Sites 1 & 2: Zymutest IgG 33 (Asserachrom Positive), 17 (Asserachrom Negative). Zymutest IgG 42 (Asserachrom Positive), 151 (Asserachrom Negative). Agreement 76%. Co-positivity 44%. Co-negativity 90%.
Reproducibility
Intra-assay: ZYMUTEST HIA Ig G and ZYMUTEST Ig GAM were tested on vials of positive control, in duplicate, taken at random from the lot. The reproducibility for Intra assay precision for the positive control was performed. The CVs are below 10%, in compliance with the specifications, and confirm an excellent homogeneity for the intra assay.
Inter assay: Tesed on one vial of positive control. The inter assay for all of the positive control results are in compliance with the specifications (CV below 10%).
Conclusion: Based on comparison with the legally marketed PF 4 Enhanced and Asserachrom devices, the data demonstrates that ZYMUTEST HIA Ig G and ZYMUTEST HIA Ig GAM devices perform as well as the predicate device and they do not present new issues of safety and effectiveness. The Intra and inter assay reproducibility of the devices (ZYMUTEST HIA Ig G and ZYMUTEST HIA Ig GAM) is within 10 % CV.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Inter-lot reproducibility & comparison with predicate (Zymutest IgGAM vs Asserachrom, 44 samples):
- Positive Agreement: 93%
- Negative Agreement: 88%
Clinical studies (Zymutest IgGAM vs Asserachrom, 243 samples):
- Agreement: 76%
- Co-positivity: 64%
- Co-negativity: 81%
Clinical studies (Zymutest IgGAM vs GTI PF4 Enhanced, 345 samples):
- Agreement: 74%
- Co-positivity: 58%
- Co-negativity: 90%
Clinical studies (Zymutest IgG vs Asserachrom, 243 samples):
- Agreement: 76%
- Co-positivity: 44%
- Co-negativity: 90%
Reproducibility:
- Intra-assay CVs: below 10%
- Inter-assay CVs: below 10%
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
510(k) #K071255
510(k) Summary
SEP - 7 2007
Submitted by:
Hyphen BioMed 95000 Neuville sur oise, France Phone # 01 34 40 65 10 Fax# 301 34 48 72 36
| Contact Person: | Dr. Jean Amiral, President & Scientific Director | |
|---|---|---|
| Summary prepared by: | April 30th 2007 | |
| Name of the Device: | ZYMUTEST HIA IgG and ZYMUTEST HIA IgGAM | |
| Classification Name: | Anti-Platelet Factor IV Complex Antibodies | |
| Regulation #: | 864.7695 | |
| Product Code: | LCO/0545 |
ldentification of Predicate device:
- ASSERACHROM ® HPIA Test Kit (Stago)
-
- PF4 ENHANCED Solid Phase ELISA (GTI)
Predicate device 510 (k) number:
Description of the Device:
The ZYMUTEST HIA is solid phase enzyme linked immunosorbent assay (ELISA) designed to detect antibodies. These antibodies are found in some patients undergoing heparin therapy.
Indication for use:
ZYMUTEST HIA IgG and IgGAM kits are designed as a solid phase enzymelinked immunosorbent assay (ELISA). These products are intended to be used as an in vitro diagnostics kit by Hematology, coagulation or other pathology laboratories to assist in screening patients samples for the presence of heparinassociated antibodies commonly found in patients with heparin induced thrombocytopenia or thrombosis (HIT).
1
Substantial equivalence is based on comparison of characteristics to the predicate devices.
ZYMUTEST HIA test kit uses the same principle as the predicate devices ASSERACHROM ®HPIA test kit and PF4 ENHANCED which are substantially equivalent in performance, intended use and technical principle.
| Item | Device (ZYMUTEST
HIA IgG and IgGAM) | Predicate
(ASSERACHROM
®HPIA) | Predicate
(PF4
Enhanced) |
|-----------------------|--------------------------------------------------------------------------|-------------------------------------|--------------------------------|
| Intended Use | Determination of anti-
heparin Platelet factor 4 | Same | Same |
| Sample
Requirement | Citrated human plasma
or Serum | Same | Same |
| Design | Sandwich technique of
enzyme-linked
immunosorbent assay
(ELISA) | Same | Same |
In addition, these products have the same indication for use and same scientific technology.
Summary of performance Data:
Inter-lot reproducibility and comparison with predicate device
- Zymutest IgGAM was compared with Asserachrom (predicate device). Total . of 44 plasma samples were analyzed. This was an internal study.
| | Asserachrom | Zymutest
IgGAM | %Agreement |
|----------|-------------|-------------------|------------|
| Positive | 28 | 30 | 93% |
| Negative | 16 | 14 | 88% |
- In clinical studies, Zymutest IgGAM was compared with Asserachrom for . n=243 plasma samples.
| Combined
Site 1 & 2 | | Asserachrom
Positive | Asserachrom
Negative |
|------------------------|--|-------------------------|-------------------------|
| Zymutest
Positive | | 48 | 32 |
| IgGAM
Negative | | 27 | 136 |
| Agreement | | 76% | |
| Co-positivity | | 64% | |
| Co-negativity | | 81% | |
| Sample Size | | 243 | |
2
- . In clinical studies, Zymutest IgGAM was compared with GTI PF4 Enhanced for n=345 plasma samples.
| Combined
Sites | GTI PF4-
Enhanced | | |
|-------------------|----------------------|----------|-----|
| 1,2,3 | Positive | Negative | |
| Zymutest
IgGAM | Positive | 101 | 17 |
| | Negative | 74 | 153 |
| Agreement | | 74% | |
| Co-positivity | | 58% | |
| Co-negativity | | 90% | |
| Sample Size | | 345 | |
- In clinical studies, Zymutest IgG was compared with Seritonin Release Assay . (SRA) for n=174 samples. Matches indicate that both were positive or both were negative.
|
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Mate
1
nes
| 0 | |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 00 |
| % Matching | Button & AMER LOUI |
- In clinical studies, Zymutest IgG was compared with Asserachrom for n=243 . samples.
| Combined
Sites 1 &
| 2 | Asserachrom | |
|---|---|---|
| Positive | Negative | |
| Zymutest | ||
| IgG | 33 | 17 |
| 42 | 151 | |
| Agreement | 76% | |
| Co-positivity | 44% | |
| Co-negativity | 90% | |
| Sample Size | 243 |
Reproducibility
Intra-assay: ZYMUTEST HIA Ig G and ZYMUTEST Ig GAM were tested on vials of positive control, in duplicate, taken at random from the lot.
| Positive control | |||
|---|---|---|---|
| Anti P | A BR CONSUL COLLEGIAN A | Carolina Art | |
| na 1947 11 | |||
| Anti I | |||
| Anti PF. | |||
| 12404 |
| | | |
3
The reproducibility for Intra assay precision for the positive control was performed. The CVs are below 10%, in compliance with the specifications, and confirm an excellent homogeneity for the intra assay.
Inter assay : Tested on one vial of positive control :
| i Positive control
| ----------- | AL FOL | |
|---|---|---|
| Int 0610270 | ||
| . In T. | AND AND OF COLLECTION COLLEGION COLLEGION | |
| GAM Int 061027G | ||
| read for the | ANNO AND OLDING & AND | |
| 1 | ||
| But Miller Councille of the career of the comparis of the comparis of the comparisms of the |
The inter assay for all of the positive control results are in compliance with the specifications (CV below 10%).
Conclusion
Based on comparison with the legally marketed PF 4 Enhanced and Asserachrom devices, the data demonstrates that ZYMUTEST HIA Ig G and ZYMUTEST HIA Ig GAM devices perform as well as the predicate device and they do not present new issues of safety and effectiveness. The Intra and inter assay reproducibility of the devices (ZYMUTEST HIA Ig G and ZYMUTEST HIA Ig GAM) is within 10 % CV.
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 eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Hyphen BioMed C/O Ola Anderson Aniara Corporation 6560 Gove Court Mason, Ohio 45040
SEP - 7 2007
Re: K071255 Trade/Device Name: Zymutest HIA IgG and Zymutest HIA IgGAM Regulation Number: 21 CFR 864.7695 Regulation Name: Platelet Factor 4 Radioimmunoassay Regulatory Class: Class II Product Code: LCO Dated: April 30, 2007 Received: May 10, 2007
Dear Mr. Anderson:
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
5
Page 2 - Ola Anderson
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 A. Becker
Robert L. Becker, M.D., Ph.D. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indication for Use Statement
510(k) Number: 071255
ZYMUTEST HIA IgG and IgGAM Device Name:
Indications for use:
ZYMUTEST HIA IgG and IgGAM kits are designed as a solid phase enzyme- linked immunosorbent assay (ELISA). These products are intended to be used as an in vitro diagnostics kit by Hematology, coagulation or other pathology laboratories to assist in screening patients samples for the presence of heparin- associated antibodies commonly found in patients with heparin induced thrombocytopenia or thrombosis (HIT).
Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jayline Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safe
510(k) K071255
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