ACON +/- MIDSTREAM PREGNANCY TEST

K050546 · ACON Laboratories, Inc. · LCX · May 20, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050546
• Device Name: ACON +/- MIDSTREAM PREGNANCY TEST
• Applicant: ACON Laboratories, Inc.
• Product Code: LCX · Clinical Chemistry
• Decision Date: May 20, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Indications for Use

The ACON +/- Midstream Pregnancy Test is for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy. It is for over-the-counter use.

Device Story

The ACON +/- Midstream Pregnancy Test is a lateral flow immunoassay for qualitative hCG detection in urine. It utilizes a color particle sandwich binding principle. The device incorporates a moisture-sensitive dye pad that changes from colorless to colored upon contact with urine, forming a '+' or '-' pattern in the result window to indicate pregnancy status. A separate control window displays a red line to confirm adequate sample volume and proper wicking. The device is intended for over-the-counter home use by lay persons. Users interpret the visual '+' or '-' result to determine pregnancy. The test has a cutoff sensitivity of 25 mIU/mL hCG. It provides a rapid, qualitative assessment to aid in pregnancy determination.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements to confirm modification meets predetermined acceptance criteria.

Technological Characteristics

Lateral flow immunoassay; color particle sandwich binding; moisture-sensitive dye pad for visual '+' or '-' result indication; control line for procedural validity; cutoff sensitivity 25 mIU/mL hCG; standardized to WHO 4th International Standard; non-interfering with LH (300 mIU/mL), FSH (1,000 mIU/mL), or TSH.

Indications for Use

Indicated for use as a diagnostic test device; patient population and specific disease state not explicitly defined in provided documentation.

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.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER K 050546

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.)
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.
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 adding a new line to form a + indicator, instead of a -.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, Addition of a moisture-sensitive dye pad, resulting in a + indicator.

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 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.