RAPIDVUE HCG TEST

K102175 · Quidel Corporation · JHI · Aug 25, 2010 · Clinical Chemistry

Device Facts

• Record ID: K102175
• Device Name: RAPIDVUE HCG TEST
• Applicant: Quidel Corporation
• Product Code: JHI · Clinical Chemistry
• Decision Date: Aug 25, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Indications for Use

The RapidVue hCG test is an immunoassay intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine for the early detection of pregnancy. The test is intended for use by health care professionals.

Device Story

RapidVue hCG test is a lateral-flow immunoassay for qualitative detection of hCG in urine; used by healthcare professionals in clinical settings. Device consists of a dipstick; user dips device into urine specimen. If hCG concentration is ≥25 mIU/mL, monoclonal antibody-coupled red-colored beads bind to hCG, forming a pink-to-red Test (T) Line on a nitrocellulose membrane; a blue procedural Control (C) Line confirms proper flow. Absence of T-line indicates hCG levels below 25 mIU/mL or absence of hCG. Results are visually interpreted by the clinician within 3 minutes to confirm pregnancy status.

Clinical Evidence

Bench testing only. Studies included assay sensitivity verification, prozone effect evaluation, urinary pH interference testing, procedural flex testing, clinical sample testing, and a Physician Office Laboratory (POL) reproducibility study. Results demonstrated performance consistency with the predicate device.

Technological Characteristics

Lateral-flow immunoassay (dipstick). Components: nitrocellulose membrane with immobilized polyclonal goat anti-alpha hCG antibody (Test Line) and protein for blue latex binding (Control Line). Indicator: monoclonal anti-hCG antibody coupled to red-colored beads. Sensitivity: 25 mIU/mL. Visual readout.

Indications for Use

Indicated for the qualitative detection of hCG in urine for early pregnancy detection in patients. Intended for use by healthcare professionals.

Regulatory Classification

Identification

A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.

Predicate Devices

• QuickVue One-Step hCG-Urine (K020799)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K102175

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 (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) QuickVue One-Step hCG-Urine, k020799

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, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for the addition of a dipstick format to the previously cleared cassette format. The dipstick format change includes the addition of polypropylene film overlapping the sample and label pads; the addition of polypropylene film (ID tape) at the upper end of the strip; and desiccant pill changed to desiccant film.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and performance characteristics included were sensitivity, prozone effect, effect of urinary pH, and procedural flex studies.

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 FMEA

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 or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

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.