K Number
K962718
Device Name
FEMEXAM TESTCARD
Date Cleared
1997-02-07

(210 days)

Product Code
Regulation Number
862.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FemExam® TestCard™ contains two qualitative, colorimetric tests for use in the characterization of a vaginal fluid sample: (1) a pH test that differentiates vaginal fluid pH less than pH 4.7 from vaginal fluid pH equal to or greater than pH 4.7; and (2) a test that detects alkali volatilizable amines in vaginal fluid.
Device Description
The FemExam® TestCard™ contains two qualitative, colorimetric tests: a pH test and an amine test. The pH test uses nitrazine yellow to produce a visual color change within two minutes of specimen application, indicating pH less than or greater than 4.7. It includes a positive procedural control and a negative background control. The amine test uses bromocresol green (BCG) and sodium aluminate to produce a visual color change within two minutes of specimen application, indicating the presence of alkali volatilizable amines. It also includes a positive procedural control and a negative background control.
More Information

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No
The device description and performance studies focus on qualitative, colorimetric chemical tests and comparisons to existing manual methods (pH test strip, whiff test), with no mention of AI or ML.

No
The device is a diagnostic tool that characterizes vaginal fluid samples by performing pH and amine tests. It does not treat or cure any condition.

Yes

The device performs qualitative, colorimetric tests to characterize vaginal fluid based on pH and the presence of alkali volatilizable amines, which are diagnostic indicators for certain vaginal conditions.

No

The device is a physical test card containing chemical reagents for colorimetric tests, not a software program.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is for "use in the characterization of a vaginal fluid sample." This involves testing a sample taken from the human body.
  • Device Description: The description details two "qualitative, colorimetric tests" that analyze the chemical properties (pH and presence of amines) of the vaginal fluid sample.
  • Performance Studies: The performance studies involve comparing the device's results to established clinical methods (commercial pH test strip and whiff test) for analyzing vaginal fluid.

These characteristics align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.

N/A

Intended Use / Indications for Use

The FemExam® TestCard™ contains two qualitative, colorimetric tests for use in the characterization of a vaginal fluid sample: (1) a pH test that differentiates vaginal fluid pH less than pH 4.7 from vaginal fluid pH equal to or greater than pH 4.7; and (2) a test that detects alkali volatilizable amines in vaginal fluid. Elevated vaginal fluid pH (pH 4.7 or higher) and the detection of a fishy odor upon adding 10% potassium hydroxide (KOH) to vaginal fluid represent two of the four Amsel criteria.

Product codes

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Device Description

The FemExam® TestCard™ pH test system contains a traditional colorimetric pH indicator, nitrazine yellow, which produces a visual, geometric color change within two minutes of specimen application. When contacted with a vaginal fluid specimen at or above pH 4.7, the pH test produces a blue plus sign against a greenish-yellow background. When contacted with a vaginal fixid specimen below pH 4.7, the pH test produces a blue minus sign against a greenish-vellow background. A narrow minus sign across the center of the pH test serves as the positive procedural control and is produced when the pH test is wetted with a vaginal fluid specimen. The positive control contains nitrazine vellow specifically formulated to change color (from greenish-yellow to blue) regardless of whether the pH of the vaginal fluid specimen is normal or elevated. Although the area surrounding the undeveloped plus sign within the pH test circle also contains nitrazine yellow, it is specifically designed not to change color, regardless of whether the pH of the vaginal fluid specimen is normal or elevated, and serves as the negative background control.

The FemExam® TestCard™ amine test system contains a traditional colorimetric pH indicator, bromocresol green (BCG), which produces a visual, geometric color change within two minutes of specimen application. When contacted with a vaginal fluid specimen that contains alkali volatilizable amines, the amine test produces a blue plus sign against a vellow background. When contacted with a vaginal fiuid specimen that does not contain alkali volatilizable amine test produces a blue minus sion against a vellow background. The TestCard™ amine test employs a very thin dried film of BCG in the yellow test circle which is surrounded by a thick black ring covered with a dried alkali, sodium aluminate. The BCG on the yellow amine test circle produces a visual color change (blue plus sign) in response to the pH elevation produced when the BCG is contacted with a vacinal fluid specimen containing amines volatilized by contact with the sodium aluminate on the thick black ring. The TestCard™ amine test detects volatile amines at concentrations above 0.5mM. A narrow blue minus sign across the center of the TestCard™ amine test serves as the positive procedural control and is produced when the amine test is wetted with a vaginal fluid specimen. The positive control contains BCG specifically formulated to change color (from yellow to blue) regardless of whether the vaginal fluid specimen does or does not contain alkali volatilizable amines. Although the area surrounding the undeveloped plus sign within the test circle also contains BCG, it is specifically designed not to change color upon the addition of the vaginal fluid specimen, regardless of whether it contains alkali volatilized amines, and serves as the negative background control.

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

Vaginal

Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies

The FemExam® TestCard™ pH and amine tests were evaluated in a statistically designed clinical study. The results of the TestCard™ pH test were compared to the results of a commercial pH test strip (ColorpHast® pH test strip) routinely used in clinical studies to estimate vaginal fluid pH. The results of the TestCard™ amine test were compared to the results of the whiff test, an accepted clinical standard for ascertaining volatile vaginal fluid amines. The positive agreement, negative agreement and overall acreement were calculated. The Test exhibited statistically significant overall agreement with the results of the pH test strip. The TestCard™ amine test exhibited statistically significant overall agreement with the results of the whiff test.

Key Metrics

positive agreement, negative agreement and overall acreement

Predicate Device(s)

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Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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§ 862.1550 Urinary pH (nonquantitative) test system.

(a)
Identification. A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.(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 § 862.9.

0

K962718

Litmus Concepts, Inc. 2981 Copper Road Santa Clara, CA 95051 (408) 245-5525 Attention: Marian B. Buccaturni July 10, 1996

FEB - 7 1997

FEMEXAM® TESTCARD™ pH AND AMINE TESTS 510(K) SUMMARY - SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR Section 807.92. Litmus Concepts, Inc. (LCI) hereby states that it will make available this safety and effectiveness information to any interested persons upon request.

1. Introduction:

The FemExam® TestCard™ contains two qualitative, colorimetric tests for use in the characterization of a vaginal fluid sample: (1) a pH test that differentiates vaginal fluid pH less than pH 4.7 from vaginal fluid pH equal to or greater than pH 4.7; and (2) a test that detects alkali volatilizable amines in vaginal fluid. Elevated vaginal fluid pH (pH 4.7 or higher) and the detection of a fishy odor upon adding 10% potassium hydroxide (KOH) to vaginal fluid represent two of the four Amsel criteria.

2. pH Test:

The FemExam® TestCard™ pH test system contains a traditional colorimetric pH indicator, nitrazine yellow, which produces a visual, geometric color change within two minutes of specimen application. When contacted with a vaginal fluid specimen at or above pH 4.7, the pH test produces a blue plus sign against a greenish-yellow background. When contacted with a vaginal fixid specimen below pH 4.7, the pH test produces a blue minus sign against a greenish-vellow background.

A narrow minus sign across the center of the pH test serves as the positive procedural control and is produced when the pH test is wetted with a vaginal fluid specimen. The positive control contains nitrazine vellow specifically formulated to change color (from greenish-yellow to blue) regardless of whether the pH of the vaginal fluid specimen is normal or elevated. Although the area surrounding the undeveloped plus sign within the pH test circle also contains nitrazine yellow, it is specifically designed not to change color, regardless of whether the pH of the vaginal fluid specimen is normal or elevated, and serves as the negative background control.

3. Amine Test:

The FemExam® TestCard™ amine test system contains a traditional colorimetric pH indicator, bromocresol green (BCG), which produces a visual, geometric color

1

1

change within two minutes of specimen application. When contacted with a vaginal fluid specimen that contains alkali volatilizable amines, the amine test produces a blue plus sign against a vellow background. When contacted with a vaginal fiuid specimen that does not contain alkali volatilizable amine test produces a blue minus sion against a vellow background.

The TestCard™ amine test employs a very thin dried film of BCG in the yellow test circle which is surrounded by a thick black ring covered with a dried alkali, sodium aluminate. The BCG on the yellow amine test circle produces a visual color change (blue plus sign) in response to the pH elevation produced when the BCG is contacted with a vacinal fluid specimen containing amines volatilized by contact with the sodium aluminate on the thick black ring. The TestCard™ amine test detects volatile amines at concentrations above 0.5mM.

A narrow blue minus sign across the center of the TestCard™ amine test serves as the positive procedural control and is produced when the amine test is wetted with a vaginal fluid specimen. The positive control contains BCG specifically formulated to change color (from yellow to blue) regardless of whether the vaginal fluid specimen does or does not contain alkali volatilizable amines. Although the area surrounding the undeveloped plus sign within the test circle also contains BCG, it is specifically designed not to change color upon the addition of the vaginal fluid specimen, regardless of whether it contains alkali volatilized amines, and serves as the negative background control.

4. Performance Characteristics:

The FemExam® TestCard™ pH and amine tests were evaluated in a statistically designed clinical study. The results of the TestCard™ pH test were compared to the results of a commercial pH test strip (ColorpHast® pH test strip) routinely used in clinical studies to estimate vaginal fluid pH. The results of the TestCard™ amine test were compared to the results of the whiff test, an accepted clinical standard for ascertaining volatile vaginal fluid amines. The positive agreement, negative agreement and overall acreement were calculated. The Test exhibited statistically significant overall agreement with the results of the pH test strip. The TestCard™ amine test exhibited statistically significant overall agreement with the results of the whiff test.