MOMENTS MENOPAUSE CHECK, MODEL 9113

K043599 · Phamatech, Inc. · CGJ · Feb 25, 2005 · Clinical Chemistry

Device Facts

• Record ID: K043599
• Device Name: MOMENTS MENOPAUSE CHECK, MODEL 9113
• Applicant: Phamatech, Inc.
• Product Code: CGJ · Clinical Chemistry
• Decision Date: Feb 25, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1300
• Device Class: Class 1

Indications for Use

The Moments Menopause Check is a rapid, qualitative immunoassay for the detection of follicle stimulating hormone (FSH) in urine. The minimum detectable concentration for this test is 25 mlU/ml. This assay is intended for use in the home to assist in the early detection of menopause.

Device Story

Moments Menopause Check is a rapid, qualitative immunoassay for home use. Device detects FSH in urine samples at a minimum concentration of 25 mlU/ml. Principle of operation is a visual color sandwich one-step immunoassay; specific antibody/FSH/labeled-antibody complexes form to indicate presence of hormone. User performs test at home; results are interpreted visually by the consumer. Device assists in early detection of menopause by identifying elevated FSH levels. Benefits include providing a preliminary screening tool for consumers to assess menopausal status.

Clinical Evidence

Performance evaluated via clinical sample correlation study and blind labeled spiked study. Laboratory studies using clinical specimens showed >98% correlation with predicate devices. Consumer study demonstrated >98% accuracy in user interpretation of results.

Technological Characteristics

Qualitative visual color sandwich one-step immunoassay. Detects FSH in urine with a sensitivity threshold of 25 mlU/ml. Device is a standalone, non-electronic, single-use test kit.

Indications for Use

Indicated for the qualitative detection of follicle stimulating hormone (FSH) in urine to assist in the early detection of menopause. Intended for over-the-counter home use.

Regulatory Classification

Identification

A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K043599

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

The change was the addition of another model (midstream format).

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics.
5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary and the Indications for Use Enclosure.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.