← Product Code [KIR](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIR) · K962306

# FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES (K962306)

_Diagnostic Hybrids, Inc. · KIR · Aug 29, 1996 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94cell-and-tissue-culture-products/KIR/K962306

## Device Facts

- **Applicant:** Diagnostic Hybrids, Inc.
- **Product Code:** [KIR](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIR.md)
- **Decision Date:** Aug 29, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.2280
- **Device Class:** Class 1
- **Review Panel:** Hematology

## 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

## Device Story

FreshCells™ A549 cell line; provided as nearly confluent monolayers; used by laboratory personnel for virus isolation and identification from clinical samples; cells susceptible to specific viruses (Adenovirus, HSV, Influenza, Measles, Mumps, Parainfluenza, Poliovirus, RSV, Rotavirus); enables viral confirmation via cell culture techniques; supports clinical diagnostic workflows.

## Clinical Evidence

Bench testing only. Characterization tests performed: appearance, growth characteristics, sterility, isoenzyme analysis, and virus susceptibility.

## Technological Characteristics

A549 cell line; provided as nearly confluent monolayers; sourced from ATCC or approved supplier; requires pre-incubation prior to use.

## Regulatory 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.

## Predicate Devices

- BioWhittaker cell cultures

## Submission Summary (Full Text)

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K962306

# AUG 29 1996

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: June 10, 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.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
HSV
Influenza
Measles
Mumps
Parainfluenza
Poliovirus
RSV
Rotavirus

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 confluent monolayers. | Cells are provided routinely as nearly confluent monolayers. | 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.

---

**Source:** [https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94cell-and-tissue-culture-products/KIR/K962306](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94cell-and-tissue-culture-products/KIR/K962306)

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