The Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide® 28 and Metricide Plus 300 Solutions (Browne Metrex 1.8% Glutaraldehyde Indicator) is a glutaraldehyde concentration monitor for use in glutaraldehyde-containing germicide solutions with a minimum effective concentration of 1.8% glutaraldehyde.

The Browne Metrex 1.8% Glutaraldehyde Indicator is dedicated for use with Metricide® 28 and Metricide Plus 30® Solutions.

Device Description

The Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide 28 and The Drownload Solution and the substantially equivalent device are chemical indicator strips intended to monitor the concentration of glutaraldehyde in glutaraldehyde-containing germicide solutions. The devices indicate, via a color change, if the germicide concentration exceeds the MEC for the solution.

The Browne Metrex 1.8% Glutaraldehyde Indicator consists of a polypropylene The Drowns 110ward results of pad on one end. The indicator pad is impregnated with an indicator solution that changes color from yellow to purple in liquid chemical germicides with a glutaraldehyde concentration above the MEC of 1.8%.

AI/ML Overview

The provided text describes a 510(k) summary for the Browne Metrex 1.8% Glutaraldehyde Indicator. It outlines the device's intended use and performance testing.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the intended use and the specific glutaraldehyde concentration thresholds. The reported performance refers to the device's ability to meet these thresholds.

Acceptance Criteria (Implied)	Reported Device Performance
Accurately indicate glutaraldehyde concentration < 1.8%	Strip appears patchy purple/yellow or yellow (at 60 secs)
Accurately indicate glutaraldehyde concentration >= 2.1%	Strip exhibits a uniform purple color (at 60 secs)
Accurately indicate glutaraldehyde concentration between 1.8-2.1%	Strip may appear yellow, purple/yellow, or purple (at 60 secs)
No false positives in solutions containing 1.8% glutaraldehyde (when used according to IFU)	"No false positives were recorded in solutions containing 1.8% glutaraldehyde, when the testing was performed according to the Instructions for Use."
Effective monitor for glutaraldehyde component of Metricide 28 and Metricide Plus 30 Solution with a MEC of 1.8%.	"The data demonstrates that the Browne Metrex 1.8% Glutaraldehyde Indicator is an effective monitor for the glutaraldehyde component of the Metricide 28 and Metricide Plus 30 Solution with a glutaraldehyde MEC of 1.8%."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document states that testing was performed in "solutions containing 1.8% and 2.1% glutaraldehyde." However, it does not specify the exact number of indicators tested or the number of solution samples used for the test set.
Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given the nature of a 510(k) submission, it is highly likely that this was a prospective, in-house laboratory study conducted by the manufacturer (Albert Browne Ltd., located in the United Kingdom).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of device (a chemical indicator strip) does not typically involve human expert interpretation for "ground truth" establishment in the same way, for example, a medical imaging AI would. The "ground truth" for the test set is the actual, measured glutaraldehyde concentration of the solutions used.

Number of Experts: Not applicable in the context of expert interpretation. The ground truth is established by chemical analysis of the solutions.
Qualifications of Experts: Not applicable for establishing ground truth for this device type. The accuracy of the glutaraldehyde concentration would rely on standard chemical laboratory practices and equipment.

4. Adjudication Method for the Test Set

Not applicable. The color change of the indicator is a direct chemical reaction, not a subjective interpretation requiring adjudication among human readers. The "reading" of the indicator is a comparison to a color chart or a visual assessment based on specific color descriptions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This device is a chemical indicator, not a diagnostic imaging or interpretive device that requires human readers. Therefore, an MRMC comparative effectiveness study is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence. The device itself is a standalone chemical indicator. Its performance is measured by its intrinsic chemical reaction and the resulting color change, without human-in-the-loop performance influencing the primary "reading" (though a human must visually interpret the color change against the provided guidance). The performance described ("No false positives were recorded...") is the standalone performance of the indicator.

7. The Type of Ground Truth Used

The ground truth used is the known, measured glutaraldehyde concentration of the germicide solutions. This would be established through a separate, calibrated chemical assay method.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning. This is a chemical indicator, not an AI/ML device that requires a training set. The performance is based on the inherent chemical properties of the indicator.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of chemical indicator. The device's mechanism is based on established chemical principles.

Summary

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K 012335

510(k) Summary

for

Browne Metrex 1.8% Glutaraldehyde Indicator for METRICIDE® 28 and METRICIDE PLUS 30° Solutions

SUBMITTER NAME AND ADDRESS 1.

Mr. Alan Charlton Albert Browne Ltd. Chancery House 190 Waterside Road Hamilton Industrial Park Leicester LE5 1QZ United Kingdom

Alan Charlton Contact: 44 116 276 8636 Telephone number:

2. DEVICE NAME

Proprietary Name:	Browne Metrex 1.8% Glutaraldehyde Indicator forMetricide® 28 and Metricide Plus 30® Solutions
Common/Usual Name:	Browne Metrex 1.8% Glutaraldehyde Indicator
Classification Name:	Physical/Chemical Sterilization Process Indicator

3. PREDICATE DEVICE

Browne GA Indicator (K922481, Albert Browne Ltd.)

4. INTENDED USE

The Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide 28 and Metricide Plus 30 Solution (Browne Metrex 1.8% Glutaraldehyde Indicator) is a glutaraldehyde concentration monitor for use in glutaraldehyde-containing germicide solutions with a minimum effective concentration (MEC) of 1.8% glutaraldehyde.

The Browne Metrex 1.8% Glutaraldehyde Indicator is dedicated for use with Metricide 28 and Metricide Plus 30 Solutions.

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DEVICE DESCRIPTION ડ.

The Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide 28 and The Drownload Solution and the substantially equivalent device are chemical indicator strips intended to monitor the concentration of glutaraldehyde in glutaraldehyde-containing germicide solutions.` The devices indicate, via a color change, if the germicide concentration exceeds the MEC for the solution.

TECHNOLOGICAL CHARACTERISTICS 6.

The technological characteristics of the Browne GA Indicator are similar to that of the Browne Metrex 1.8% Glutaraldehyde Indicator described in this Both devices are non-sterile, disposable strips containing an submission. indicator pad impregnated with an indicator solution that changes color in a germicide solution at the appropriate glutaraldehyde concentration.

The mechanism of action for inducing a color change is identical for the Browne 1.8% Glutaraldehyde Indicator and the Browne GA Indicator. Metrex Medex 11070 reacts with sodium sulfite in the test strip to form a sulfite addition product and an equivalent amount of base. If sufficient glutaraldehyde is present, the increase in pH causes a color change in the pH indicator.

The indicator color is dependent upon the glutaraldehyde concentration of the germicide solution, and the time after exposure when the results of the test are read, as described in the table below.

Time(minutes)	Glutaraldehyde Concentration (%)
	<1.8	1.8-2.1	>2.1
<1	yellow, purple/yellow	yellow, purple/yellow
1-2	yellow,purple/yellow	yellow, purple/yellow,purple	purple
>2		yellow, purple/yellow

Color Development for the Metrex 1.8% Glutaraldehyde Indicator Strip

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During the first 60 seconds after the test strip has been dipped into the Metricide 28 or Metricide Plus 30 Solution, the yellow test strip will begin to develop a purple color.

At 60 seconds (one minute), the strip will exhibit a uniform purple color (except for the top 2 mm of the strip) if the concentration of glutaraldehyde is >2.1. The strip will appear patchy purple/yellow or yellow if the solution contains <1.8% glutaraldehyde. In the concentration range of 1.8 to 2.1, the strip may appear yellow, purple/yellow, or purple.

From 60 to 120 Seconds (one to two minutes) the color of the strip is stable. A color reading must be taken during this time period for the results to accurately reflect the glutaraldehyde concentration of the Metricide 28 or Metricide Plus 30 Solution.

After 120, seconds (two minutes) the color of the strip regresses toward the original yellow color. The rate of regression is dependent on the glutaraldehyde concentration of the Metricide 28 and Metricide Plus 30 Solution being tested.

7. PERFORMANCE TESTING

The performance characteristics of the Browne Metrex 1.8% Glutaraldehyde Indicator were established by testing indicators in Metricide 28 and Metricide Plus 30 Solutions containing 1.8% and 2.1% glutaraldehyde. No false positives were recorded in solutions containing 1.8% glutaraldehyde, when the testing was performed according to the Instructions for Use. The data demonstrates that the Browne Metrex 1.8% Glutaraldehyde Indicator is an effective monitor for the glutaraldehyde component of the Metricide 28 and Metricide Plus 30 Solution with a glutaraldehyde MEC of 1.8%.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus-like symbol with three diagonal lines converging into a single point, resembling a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Albert Browne Limited C/O Ms. Cynthia J.M. Nolte Staff Consultant Medical Device Consultants 49 Plain Street North Attleboro. Massachusetts 02760

Re: K012335

Trade/Device Name: Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide® 28 and Metricide Plus 30® Solutions Regulation Number: 880.2800 Regulation Name: Browne Metrex 1.8% Glutaraldehyde Indicator Regulatory Class: II Product Code: JOJ Dated: July 23, 2001 Received: July 24, 2001

OCT - 1 2001

Dear Ms. Nolte:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (section 531-542 of the Act; 21): CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

[signature]

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known): K012335

Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide® 28 and Device Name: Metricide Plus 300 Solutions

Indications for Use:

The Browne Metrex 1.8% Glutaraldehyde Indicator is dedicated for use with Metricide® 28 and Metricide Plus 30® Solutions.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Phin S. Lim

(Division Sign-Off) (Division of Dental, Infection Control, and General Hospital Devic 510(k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use X

July 23, 2001 Albert Browne Ltd. Browne Metrex 1.8% Glutaraldehyde Indicator 510(k)

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).