E.P.T. CERTAINTY PREGNANCY TEST

K050930 · Unipath , Ltd. · LCX · May 12, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050930
• Device Name: E.P.T. CERTAINTY PREGNANCY TEST
• Applicant: Unipath , Ltd.
• Product Code: LCX · Clinical Chemistry
• Decision Date: May 12, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

e.p.t Certainty™ Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from the first day of the expected period and thereafter, but can also be used from three days before the expected period.

Device Story

e.p.t Certainty™ Pregnancy Test is an over-the-counter, single-use diagnostic device for home pregnancy detection. It detects human chorionic gonadotropin (hCG) in urine samples. The device modification allows for early testing, specifically up to 3 days prior to the expected menstrual period. The device functions similarly to previously cleared digital pregnancy tests, utilizing established immunoassay technology to provide a qualitative result. The user performs the test at home and interprets the result directly from the device display. The output assists the user in determining pregnancy status, facilitating early clinical or personal decision-making.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by design control activities, risk analysis, and verification/validation testing confirming the performance of the modified device meets predetermined acceptance criteria.

Technological Characteristics

Lateral flow immunoassay for qualitative hCG detection. Form factor is a handheld, single-use test device. No software or electronic components.

Indications for Use

Indicated for the detection of pregnancy in women via urine hCG testing. Can be used starting three days before the expected period and thereafter.

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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MAY 1 2 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Louise Roberts Regulatory Affairs Manager Unipath Ltd. Priory Business Park Bedford MK44 3UP United Kingdom

k050930 Re:

K050750
Trade/Device Name: e.p.t CertaintyTM Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: April 12, 2005 Received: April 14, 2005

Dear Ms. Roberts:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave levice your becaon 310(s) person station is substantially equivalent (for the indications felerenced above and nave determined ly marketed predicate devices marketed in interstate for use stated in the cherosury to regars actment date of the Medical Device Amendments, or to commence provision in May 20, 1976, the excordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Costinetic Act (71ct) that to neview, subject to the general controls provisions of the Act. The 1 ou may, mercetore, market the act include requirements for annual registration, listing of general controls provisions of uactice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device It may be subject it Juden additions (CFR), Parts 800 to 895. In additions (CFR), Parts 800 to 895 can be found in Ther 21, cooments concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least be advised that I Dris issualles over device complies with other requirements of the Act that I DA has made a decerminations administered by other Federal agencies. You must of ally it catal statutes and regarants ancluding, but not limited to: registration and listing (21 Comply with and the of require.Rents 801 and 809); and good manufacturing practice CFR Part 807), laoemig as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in you to ough finding of substantial equivalence of your device to a legally premarce notification - The sults in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In of quostons on the promostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may other of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benem

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

e.p.t CertaintyTM Pregnancy Test Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

e.p.t Certainty™ Pregnancy Test is an over-the-counter urine hCG test which is e.p. Cenamily - 1 regriancy Toot is and of The test is indicated for use from the first day intended for the detootion of pregriting.
of the expected period and thereafter, but can also be used from three days before the expected period.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Albert S.

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

53030 K05030

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