(73 days)
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No
The summary describes a cell culture product for virus isolation, with no mention of AI or ML technology in the intended use, device description, or performance studies.
No
Explanation: This device is a cell line used for virus isolation and identification in diagnostic settings, not for treating diseases or conditions.
No
The device is a cell line (A549 cells) used to culture viruses for isolation and identification. It is a tool or reagent used in the diagnostic process, rather than a diagnostic device that performs the final diagnosis itself.
No
The device description explicitly states it provides "A549 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 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 medical device intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The device provides A549 cells as a tool for performing these in vitro 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," which further supports its use in diagnostic procedures.
- Predicate Device: The predicate device is also described as "cell cultures," implying that similar products are already classified as medical devices, likely IVDs.
The information provided clearly indicates that this device is intended to be used outside of the human body to analyze human specimens (clinical samples) for diagnostic purposes (virus isolation and identification).
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, A549, is susceptible to and can be used in the isolation and confirmation of the following viruses from clinical samples: Adenovirus, HSV, Influenza, Measles, Mumps, Parainfluenza, Poliovirus, RSV, Rotavirus.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The subject device provides A549 cells as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period.
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 tharacteristics, sterility, isoenzyme analysis and virus susceptibility. of specific viruses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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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 . I . l President Street Athens, OH 45701 (614) 593-1784 FAX: (614) 593-0980 Attn: J.L. Brown Date of Preparation: June 10, 1996
ここでなること
- a . 2 . Trade Name: FreshCells™ Classification Name: Cells, Animal and Human, Cultured.
- A predicate device is that of BioWhittaker, marketed as cell cultures, a.3. Appendix II, p.18 of this 510(k) Notification.
- a . 4 . The subject device provides A549 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, A549, is susceptible to and can be used in the isolation and confirmation of the following viruses from clinical samples:
| Adenovirus | Parainfluenza |
|---|---|
| HSV | Poliovirus |
| Influenza | RSV |
| Measles | Rotavirus |
| Mumps |
- 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. |
b.1. The non-clinical tests consist of those used to characterize the product such as appearance, growth tharacteristics, sterility, isoenzyme analysis and virus susceptibility.
of specific viruses.
Not applicable. b.2.
b.3. Not applicable.