(73 days)
K/DEN number:
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No
The 510(k) summary describes a cell line for virus isolation and identification, with no mention of AI or ML technology in the intended use, device description, or performance studies.
No
The device provides cell cultures for virus isolation and identification, it is not used to treat a disease or condition.
No.
The device provides cell cultures used for virus isolation and identification, but it does not directly perform the diagnostic function itself; it is a reagent for diagnostic testing.
No
The device description clearly states it provides "frozen A549 cells in measured quantities," indicating a physical biological product, not software.
Based on the provided information, 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 in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnosis, treatment, or prevention of disease.
- Device Description: The device provides cells that are used to create monolayers for "virus isolation and identification." This is a key step in many diagnostic procedures for viral infections.
- Performance Studies: The non-clinical tests include "virus susceptibility," which is a performance characteristic relevant to the diagnostic use of the cells.
- Predicate Device: The predicate device is described as "cell cultures, Cryopreserved ampules," which are commonly used in IVD workflows for viral diagnostics.
The device is a reagent or component used within an in vitro diagnostic procedure. While it doesn't perform the entire diagnostic test itself, it is an essential part of the process for isolating and identifying viruses 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 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
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Device Description
The subject device provides frozen A549 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)
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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.
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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: June 10, 1996
- a.2. Trade Name: FreshFrozenCells™ 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.18 of this 510(k) Notification.
- The subject device provides frozen A549 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 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 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.
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