(63 days)
Cell cultures to be used as hosts for the isolation and identification of specific viruses. The subject of this 510(k) Notification, the cell lines HEL, HFF, LLC-MK2, Mv1Lu, NCI H292, Vero and WI-38 are susceptible to and can be used in the isolation and confirmation of the following viruses from clinical samples: Adenovirus, CMV, Echovirus, HSV, Poliovirus, Rhinovirus, Vesicular stomatitis (Indiana Strain) virus and VZV; Adenovirus, CMV, Echovirus, HSV, Mumps, Poliovirus, Rhinovirus, VZV; Poliovirus type 1, Enterovirus, Rhinovirus, Myxovirus and Poxvirus groups; HSV, CMV; Vaccinia virus, HSV, Adenovirus, BK polyomavirus, Reoviruses, Measles virus, RSV, some strains of Influenza type A, most Enteroviruses and Rhinoviruses, Parainfluenza and Mumps; Adenovirus, Coxsackie B, HSV, Measles, Mumps, Poliovirus type 3, Rotavirus, Rubella; Adenovirus, CMV, Echovirus, HSV, Influenza, Mumps, Poliovirus, Rhinovirus, RSV, VZV.
FreshCells™ are indicated for use in the isolation of various viruses and Chlamydia from clinical specimens.
The subject device provides HEL, HFF, LLC-MK2, Mv1Lu, NCI H292, Vero and WI-38 cells (in addition to MRC-5, McCOY, BGMK, and CV-1, under 510 (k) K936271 and A549 and HEp-2, under 510(k) K962306 which have previously been cleared for marketing under the same name, Fresh Cells™) as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period.
The provided K773414 510(k) summary describes the submission for "FreshCells™," which are cultured cells intended for use as hosts for the isolation and identification of specific viruses. This document establishes substantial equivalence to a predicate device and focuses on the characterization and performance of these cell lines.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device) |
|---|---|---|
| Source of Cell Line | ATCC or another approved supplier. | Same as predicate device (ATCC or approved supplier). |
| Provided as nearly confluent monolayers | Cells are provided routinely as nearly confluent monolayers. | Same as predicate device (nearly confluent monolayers). |
| Intended Use | Isolation & Confirmation of specific viruses. | Same as predicate device (Isolation & Confirmation of specific viruses). |
| Growth Characteristics | (Implied: Normal and robust growth for cell culture applications) | Characterized (Non-clinical tests performed). |
| Sterility | (Implied: Sterile for cell culture applications) | Characterized (Non-clinical tests performed). |
| Isoenzyme Analysis | (Implied: Consistent and appropriate isoenzyme profiles) | Characterized (Non-clinical tests performed). |
| Virus Susceptibility (Cell Line/Virus Specific) | Predicate device demonstrated susceptibility to viruses relevant to its intended use. | Subject device demonstrated susceptibility to a list of specific viruses for each proposed cell line (HEL, HFF, LLC-MK2, MvlLu, NCI H292, Vero, WI-38). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of an algorithm or diagnostic model. The evaluation here is for cell cultures. The "testing" refers to the characterization and virus susceptibility studies performed on the subject FreshCells™ lines.
- Sample Size: Not explicitly stated in terms of a numerical count for a test set. This refers to the batches of cells produced and tested during characterization and virus susceptibility studies.
- Data Provenance: The studies were performed by Diagnostic Hybrids, Inc. The data would be prospective in the sense that the characterization and susceptibility testing were performed on newly produced batches of FreshCells™ as part of the validation process. The country of origin is implicitly the United States, where Diagnostic Hybrids, Inc. is located.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this 510(k) submission. "Ground truth" in this context is established through standard laboratory methods for cell culture characterization and virology testing (e.g., observing cytopathic effect, immunofluorescence, PCR, etc., which are common laboratory techniques). There is no mention of human experts establishing a subjective "ground truth" for a test set in the way one might for image interpretation or disease diagnosis.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of an adjudication process as there would be for subjective interpretations (e.g., imaging reads). The results of cell culture characterization and virus susceptibility testing are typically determined by objective laboratory assays.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This submission is for cultured cells, not an AI-powered diagnostic device or an imaging system that would involve human "readers" or an AI component.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm or AI component in this device.
7. The Type of Ground Truth Used
The "ground truth" for this device, which refers to the expected biological behavior and characteristics of the cell lines, is established through:
- Standard Laboratory Assays: This includes macroscopic and microscopic observation of cell growth, morphology, sterility testing, and isoenzyme analysis (to confirm cell line identity).
- Established Virology Protocols: For virus susceptibility, the ground truth is whether a specific cell line reliably supports the replication and identification of a given virus, which is determined by inoculating the cells with known viral strains and observing cytopathic effects or other established detection methods. This is based on decades of virology research and established scientific literature on viral tropism.
8. The Sample Size for the Training Set
Not applicable. As this is not an AI or machine learning device, there is no "training set" in the conventional sense. The development of the FreshCells™ lines relies on established cell culture techniques and knowledge from continuously maintaining and characterizing these cell lines over time.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an algorithm. The "knowledge base" for developing and characterizing these cell lines comes from:
- Scientific Literature and ATCC standards: Established characteristics and maintenance protocols for cell lines obtained from sources like ATCC.
- Internal Quality Control Data: Ongoing in-house testing and characterization of cell batches over their production history to ensure consistency and meet specifications. The submission mentions "non-clinical tests consist of those used to characterize the product such as appearance, growth characteristics, sterility, isoenzyme analysis and virus susceptibility," which collectively form the basis of the "ground truth" for these cell lines.
§ 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.