Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart C — General Hospital and Personal Use Monitoring Devices](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices) → [21 CFR 880.2800](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/880.2800) → MRB — Indicator, Biological, Liquid Chemical Sterilization Process

# MRB · Indicator, Biological, Liquid Chemical Sterilization Process

_General Hospital · 21 CFR 880.2800 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/MRB

## Overview

- **Product Code:** MRB
- **Device Name:** Indicator, Biological, Liquid Chemical Sterilization Process
- **Regulation:** [21 CFR 880.2800](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/880.2800)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)
- **3rd-party reviewable:** yes

## Identification

Biological sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. Physical/chemical sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K081879](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/MRB/K081879.md) | SPSMEDICAL SPORVIEW PA CULTURE SET | Spsmedical Supply Corp. | Jul 30, 2008 | SESE |
| [K053212](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/MRB/K053212.md) | RAVEN PROPACT | Raven Biological Laboratories, Inc. | Feb 15, 2006 | SESE |
| [K043135](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/MRB/K043135.md) | SPSMEDICAL SPORVIEW PA CULTURE SET | Spsmedical Supply Corp. | Jan 13, 2005 | SESE |
| [K031114](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/MRB/K031114.md) | PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA | Raven Biological Laboratories, Inc. | Mar 3, 2004 | SESE |

## Top Applicants

- Raven Biological Laboratories, Inc. — 2 clearances
- Spsmedical Supply Corp. — 2 clearances

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/MRB](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/MRB)

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