(126 days)
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).
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.
The provided 510(k) summary describes the ZYMUTEST HIA IgG and ZYMUTEST HIA IgGAM devices, which are ELISA kits designed to detect heparin-associated antibodies related to Heparin Induced Thrombocytopenia (HIT). The submission establishes substantial equivalence to existing predicate devices (ASSERACHROM ®HPIA Test Kit and PF4 ENHANCED Solid Phase ELISA).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly based on establishing substantial equivalence with the predicate devices. The primary performance metrics reported are agreement, co-positivity, and co-negativity with the predicate devices, along with intra- and inter-assay reproducibility. Specific numerical acceptance criteria are not explicitly stated as target percentages for agreement, co-positivity, or co-negativity, but the general conclusion implies that the observed values meet the FDA's criteria for substantial equivalence.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Agreement (vs. Predicate) | Sufficient agreement to demonstrate substantial equivalence | Zymutest IgGAM vs. Asserachrom (n=243): 76% |
| Zymutest IgGAM vs. GTI PF4 Enhanced (n=345): 74% | ||
| Zymutest IgG vs. Asserachrom (n=243): 76% | ||
| Co-positivity (vs. Predicate) | Sufficient co-positivity to demonstrate substantial equivalence | Zymutest IgGAM vs. Asserachrom (n=243): 64% |
| Zymutest IgGAM vs. GTI PF4 Enhanced (n=345): 58% | ||
| Zymutest IgG vs. Asserachrom (n=243): 44% | ||
| Co-negativity (vs. Predicate) | Sufficient co-negativity to demonstrate substantial equivalence | Zymutest IgGAM vs. Asserachrom (n=243): 81% |
| Zymutest IgGAM vs. GTI PF4 Enhanced (n=345): 90% | ||
| Zymutest IgG vs. Asserachrom (n=243): 90% | ||
| Intra-assay Reproducibility | CV below 10% | CVs below 10% (for positive control) |
| Inter-assay Reproducibility | CV below 10% | CVs below 10% (for positive control) |
2. Sample Size for the Test Set and Data Provenance
- Zymutest IgGAM vs. Asserachrom (internal study): 44 plasma samples. Provenance not specified, but stated as an "internal study," suggesting it was conducted by Hyphen BioMed. Retrospective or prospective nature is not specified.
- Zymutest IgGAM vs. Asserachrom (clinical studies): 243 plasma samples. Provenance from "Combined Site 1 & 2." Specific country of origin or whether retrospective/prospective is not specified.
- Zymutest IgGAM vs. GTI PF4 Enhanced (clinical studies): 345 plasma samples. Provenance from "Combined Sites 1,2,3." Specific country of origin or whether retrospective/prospective is not specified.
- Zymutest IgG vs. Serotonin Release Assay (SRA) (clinical studies): 174 samples. Provenance not specified. This appears to be a reference method rather than a predicate.
- Zymutest IgG vs. Asserachrom (clinical studies): 243 samples. Provenance from "Combined Sites 1 & 2." Specific country of origin or whether retrospective/prospective is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The ground truth for the comparison studies was established by the predicate devices (ASSERACHROM ®HPIA and PF4 ENHANCED) and the Serotonin Release Assay (SRA). There is no mention of human experts being used to establish ground truth for the test set; instead, the results of existing, legally marketed diagnostic tests are used as the reference.
4. Adjudication Method for the Test Set
Not applicable. The comparisons are directly against the results of the predicate devices or the SRA, not against expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is an in vitro diagnostic device, and the evaluation focuses on its performance compared to other diagnostic assays, not on human reader performance with or without AI assistance.
6. Standalone Performance Study
Yes, the studies presented are standalone performance studies of the ZYMUTEST HIA IgG and IgGAM devices, comparing their results directly with established predicate devices and a reference method (SRA). The performance metrics (agreement, co-positivity, co-negativity, reproducibility) characterize the algorithm's (device's) performance.
7. Type of Ground Truth Used
The ground truth used for the comparison studies was the results obtained from legally marketed predicate in vitro diagnostic devices (ASSERACHROM ®HPIA and PF4 ENHANCED) and a reference assay (Serotonin Release Assay - SRA). This falls under the category of using established, validated diagnostic tests as the reference standard.
8. Sample Size for the Training Set
The document does not provide information about a "training set" in the context of machine learning or AI. This device is an ELISA kit, not an AI-powered diagnostic system. The validation studies instead compare the device's performance against existing methods.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no mention of a training set for machine learning or AI in this 510(k) submission.
§ 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).