(43 days)
No
The summary describes a cell culture product for virus isolation and identification, with no mention of AI or ML technology.
No
Explanation: This device is for virus isolation and identification in cell cultures, not for treating a disease or condition.
Yes
The device, a cell line, is used for the "isolation and confirmation of ... viruses from clinical samples," which is a diagnostic purpose.
No
The device description clearly states it provides "HEp-2 cells as nearly confluent monolayers," which are biological materials and not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly 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 in vitro diagnostic product, which is used to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The device provides HEp-2 cells as a tool for performing these diagnostic tests.
- Performance Studies: The summary of performance studies mentions "non-clinical tests consist of those used to characterize the product such as... virus susceptibility of specific viruses." This further supports its use in a diagnostic context.
- Predicate Device: The predicate device is also described as "cell cultures," which are commonly used in IVD applications for viral isolation.
The information provided strongly indicates that this device is intended for use in a laboratory setting to diagnose viral infections by isolating and identifying viruses from patient samples, which is the core function of an IVD.
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 line, HEp-2, is susceptible to and can be used in the isolation and confirmation of the following viruses from clinical samples:
| Adenovirus | Parainfluenza |
|---|---|
| HSV | Poliovirus |
| Coxsackie B | RSV |
| Measles |
Product codes
Not Found
Device Description
The subject device provides HEp-2 cells as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period.
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
Not Found
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
The non-clinical tests consist of those used to characterize the product such as appearance, growth characteristics, sterility, isoenzyme analysis and virus susceptibility.
of specific viruses.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 9 199
510 (k) Summary
- a.1. Diagnostic Hybrids, Inc. 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: FreshCells™ Classification Name: Cells, Animal and Human, Cultured.
- a.3. A predicate device is that of BioWhittaker, marketed as cell cultures, Appendix II, p.19 of this 510 (k) Notification.
- a.4. The subject device provides HEp-2 cells as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period.
- a.5. Intended Use: Cell cultures to be used for specific virus isolation and identification. The subject of this 510(k) Notification, the cell line, HEp-2, is susceptible to and can be used in the isolation and 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 as nearly con- | ||
| fluent monolayers. | Cells are provided | |
| routinely as nearly | ||
| confluent monolayers. | Same as predicate device. | |
| Intended Use. | Isolation & Confirmation | Same as predicate device. |
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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.
of specific viruses. -
b.2. Not applicable.
-
b.3. Not applicable.