PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA

• K Number: K031114
• Device Name: PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA
• Manufacturer: RAVEN BIOLOGICAL LABORATORIES, INC.
• Date Cleared: 2004-03-03 ( 330 days)
• Product Code: MRB
• Regulation Number: 880.2800
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

The Raven ProPACT Peracetic Acid Culture Test Kit is intended for use with STERIS SYSTEM 1™, a liquid chemical sterilization system. The ProPACT Peracetic Acid Culture Test Kit provides independent confirmation that sterilization conditions were achieved during the STERIS SYSTEM 1 processing cycle. A reduced incubation time of 48 hours has been validated for the Raven ProPACT Peracetic Acid Culture Test Kit.

Device Description

Not Found

AI/ML Overview

Because the provided text is a regulatory 510(k) clearance letter from the FDA, it outlines the regulatory approval for a medical device but does not contain the detailed scientific study information requested. The letter confirms substantial equivalence to a predicate device and provides general information about regulatory compliance. It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance, or the number/qualifications of experts.
3. Adjudication methods.
4. Information on MRMC studies or effect sizes.
5. Standalone algorithm performance.
6. Type of ground truth used.
7. Sample size for the training set or how its ground truth was established.

Therefore, I cannot fulfill your request with the provided input. This document serves as a regulatory approval notice, not a scientific study report.

Regulation Number and Section

§ 880.2800 Sterilization process indicator.

(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is 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.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is 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.(2)
Classification. Class II (performance standards).