(43 days)
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No
The summary describes a biological product (cell cultures) used for virus isolation and identification. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI or ML.
No
This device, HEp-2 cell line, is used for virus isolation and identification in laboratory settings, not for treating diseases or conditions.
No
The device provides cell cultures for virus isolation and identification. While these cells are used in a laboratory process that contributes to diagnosis, the device itself is a reagent and not a diagnostic device that directly performs a diagnostic function on a clinical sample.
No
The device is a physical product (frozen cell cultures) and does not describe any software component.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the cell cultures are "to be used for specific virus isolation and identification" from "clinical samples." This directly aligns with the definition of an IVD, which is a device intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease.
- Device Description: The device provides cells that are used as a tool in a diagnostic process (virus isolation and identification).
- Performance Studies: The performance studies mentioned (sterility, virus susceptibility) are relevant to ensuring the quality and suitability of the cells for their intended diagnostic purpose.
- Predicate Device: The predicate device is also described as "cell cultures," further indicating that this type of product is considered an IVD.
The lack of information regarding image processing, AI/ML, anatomical site, patient age, intended user, and detailed performance metrics is common for certain types of IVDs, particularly those that are reagents or components used within a larger diagnostic workflow. The core function of this device is to provide a biological reagent (cells) for a diagnostic test (virus isolation and identification from clinical samples).
N/A
Intended Use / Indications for Use
Cell cultures to be used for specific virus isolation and identification. The subject of this 510(k) Notification, the cell HEp-2, is susceptible to and can be used in the isolation and line, confirmation of the following viruses from clinical samples: Adenovirus, HSV, Coxsackie B, Measles, Parainfluenza, Poliovirus, RSV.
Product codes
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Device Description
The subject device provides frozen HEp-2 cells in measured quantities allowing the user to simply thaw and dilute the cells to a prescribed volume, plant prescribed volumes in appropriate containers and after a few days, the cell monolayers will be confluent and ready to use for virus isolation and identification.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The non-clinical tests consist of those used to characterize the product such as appearance, growth characteristics, sterility, isoenzyme analysis and virus susceptibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
a.3. A predicate device is that of BioWhittaker, marketed as cell cultures, Cryopreserved ampules, Appendix II, p.19 of this 510(k) Notification.
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 864.2280 Cultured animal and human cells.
(a)
Identification. Cultured animal and human cells are in vitro cultivated cell lines from the tissue of humans or other animals which are used in various diagnostic procedures, particularly diagnostic virology and cytogenetic studies.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
0
AUG 2 9 1996
510 (k) Summary
- Diagnostic Hybrids, Inc. a.1. 1 President Street Athens, OH 45701 (614) 593-1784 FAX: (614) 593-0980 Attn.: J.L. Brown Date of Preparation: July 12, 1996
- a.2. Trade Name: FreshFrozen Cells™ Classification Name: Cells, Animal and Human, Cultured.
- a.3. A predicate device is that of BioWhittaker, marketed as cell cultures, Cryopreserved ampules, Appendix II, p.19 of this 510(k) Notification.
- The subject device provides frozen HEp-2 cells in measured quantities a.4. allowing the user to simply thaw and dilute the cells to a prescribed volume, plant prescribed volumes in appropriate containers and after a few days, the cell monolayers will be confluent and ready to use for virus isolation and identification.
- a.5. Intended Use: Cell cultures to be used for specific virus isolation and identification. The subject of this 510(k) Notification, the cell HEp-2, is susceptible to and can be used in the isolation and line, confirmation of the following viruses from clinical samples:
| Adenovirus | Parainfluenza |
|---|---|
| HSV | Poliovirus |
| Coxsackie B | RSV |
| Measles |
- a. 6. A comparison of Technological Characteristics:
| Characteristics | Predicate Device | Subject Device |
|---|---|---|
| Source of Cell Line | ATCC or another | |
| approved supplier. | Same as predicate | |
| device. | ||
| Provided Frozen | Cells can be stored | |
| frozen for months | ||
| prior to thawing for | ||
| use. | Same as predicate | |
| device. | ||
| Intended Use | Isolation & Confirmation | |
| of specific viruses. | Same as predicate | |
| device. |
- b.1. The non-clinical tests consist of those used to characterize the product such as appearance, growth characteristics, sterility, isoenzyme analysis and virus susceptibility.
- b.2. Not Applicable.
- b.3. Not Applicable.