PHEM-ALERT

K032161 · Femtek,Llc. · LNW · Sep 30, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032161
• Device Name: PHEM-ALERT
• Applicant: Femtek,Llc.
• Product Code: LNW · Clinical Chemistry
• Decision Date: Sep 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1550
• Device Class: Class 1

Indications for Use

The pHEM-ALERT® test measures vaginal pH and is intended for use by women who have any of the following vaginal symptoms: Itching – burning – unpleasant odor – unusual discharge This test may help decide if these symptoms are caused by an infection that may require follow-up by your healthcare provider. This test is only intended for women who have normal menstrual periods (periodic vaginal bleeding) or who may currently be pregnant. If you are pregnant, always discuss your symptoms and the result of this test with your healthcare provider and NEVER treat yourself.

Device Story

pHEM-ALERT® is an OTC vaginal pH test; used by women experiencing vaginal symptoms (itching, burning, odor, discharge). Device consists of a probe with mounted pH paper; user applies vaginal secretion to the probe; color change indicates pH level. Results assist users in determining need for professional medical consultation. Device is a physical modification of the predicate (K012230), featuring a thinner, rounded probe design. Intended for both non-pregnant and pregnant symptomatic women.

Clinical Evidence

No new clinical data provided; relies on performance characteristics established in predicate K012230.

Technological Characteristics

Qualitative vaginal pH test; probe-based form factor with pH-sensitive paper. Physical design: thin, rounded probe end. OTC use; no instrumentation required.

Indications for Use

Indicated for women with vaginal symptoms (itching, burning, unpleasant odor, unusual discharge) who have normal menstrual periods or are pregnant, to assist in deciding if follow-up with a healthcare provider is required.

Regulatory Classification

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.

Predicate Devices

• pHEM-ALERT® (K012230)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
K032161

B. Analyte:
Vaginal pH

C. Type of Test:
Qualitative

D. Applicant:
FemTek, LLC

E. Proprietary and Established Names:
pHEM-ALERT®

F. Regulatory Information:
1. Regulation section:
21 CFR 862.1550
2. Classification:
Class I
3. Product Code:
LNW
4. Panel:
75

G. Intended Use:
1. Intended use(s):
The pHEM-ALERT® test measures vaginal pH and is intended for use by women who have any of the following vaginal symptoms:
Itching – burning – unpleasant odor – unusual discharge

This test may help decide if these symptoms are caused by an infection that may require follow-up by your healthcare provider. This test is only intended for women who have normal menstrual periods (periodic vaginal bleeding) or who may currently be pregnant. If you are pregnant, always discuss your symptoms and the result of this test with your healthcare provider and NEVER treat yourself.

2. Indication(s) for use:
The pHEM-ALERT® test measures vaginal pH and is intended for use by women who have any of the following vaginal symptoms:
Itching – burning – unpleasant odor – unusual discharge

This test may help decide if these symptoms are caused by an infection that may require follow-up by your healthcare provider. This test is only intended for women who have normal menstrual periods (periodic vaginal bleeding) or who may currently be pregnant. If you are pregnant, always discuss your

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symptoms and the result of this test with your healthcare provider and NEVER treat yourself.

3. Special condition for use statement(s):
This device is intended for over-the-counter (OTC) use.
4. Special instrument Requirements:
Not applicable

H. Device Description:
See K012230.

I. Substantial Equivalence Information:
1. Predicate device name(s):
pHEM-ALERT®
2. Predicate K number(s):
K012230
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | | |
| Differences | | |
| Item | Device | Predicate |
| Indications for Use | Symptomatic nonpregnant and pregnant women | Symptomatic nonpregnant women only |
| Limitation | Removed statement/ remained silent | Not a test for Group B Streptococcus |
| Physical Dimensions | Thinner with a round probe end and round pH paper mounted on the end | Rectangular probe end and rectangular pH paper mounted on the end |

J. Standard/Guidance Document Referenced (if applicable):
Not applicable

K. Test Principle:
See K012230.

L. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Not applicable
b. Linearity/assay reportable range:
Not applicable
c. Traceability (controls, calibrators, or method):
Not applicable
d. Detection limit:
Not applicable
e. Analytical specificity:
Not applicable

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f. Assay cut-off:
Not applicable

2. Comparison studies:
a. Method comparison with predicate device:
Not applicable
b. Matrix comparison:
Not applicable

3. Clinical studies:
a. Clinical sensitivity:
See K012230.
b. Clinical specificity:
See K012230.
c. Other clinical supportive data (when a and b are not applicable):
See K012230.

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
See K012230.

M. Conclusion:
The minor physical changes made to the device and labeling revisions do not raise any issues of safety and effectiveness. Therefore, it is recommended that the pHEM-ALERT® device be found substantially equivalent.