UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP

K131236 · Ucp Biosciences, Inc. · LCX · Nov 7, 2013 · Clinical Chemistry

Device Facts

• Record ID: K131236
• Device Name: UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP
• Applicant: Ucp Biosciences, Inc.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Nov 7, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Indications for Use

UCP Home Pregnancy Cassette Test is rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The device is intended for Over the Counter Use Only. UCP Home Pregnancy Dip Card/Strip is rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The device is intended for Over the Counter Use Only. UCP Home Pregnancy Midstream Test is rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The device is intended for Over the Counter Use Only. UCP Pregnancy Cassette Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The device is intended for Prescription Use Only including at point of care sites. UCP Pregnancy Dip Card/Strip is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The device is intended for Prescription Use Only including at point of care sites.

Device Story

Rapid chromatographic lateral flow immunoassay for qualitative hCG detection in urine; detects pregnancy. Formats include midstream, dip card/strip, and cassette. No instrumentation required; visual interpretation of results. Used in home settings by lay users or point-of-care settings by professionals. Provides qualitative result (positive/negative) based on presence of hCG; aids clinical decision-making regarding pregnancy status. Benefits patient through early pregnancy detection.

Clinical Evidence

Clinical study with 100 urine specimens from women of childbearing age (suspected pregnant, early pregnancy, first trimester). Comparison between subject device and predicate performed by lab professionals showed 100% agreement. Consumer study with 100 lay users showed 100% agreement with professional results. Lay users confirmed ease of use and interpretation.

Technological Characteristics

Lateral flow immunoassay using nitrocellulose membrane strips. Employs monoclonal (mouse) and polyclonal (goat) antibodies with colloidal gold conjugate for visualization. Sensitivity: 25 mIU/mL. Formats: Midstream, Dip Card/Strip, Cassette. No electronic components or software. Shelf life: 24 months at 15-28°C.

Indications for Use

Indicated for qualitative detection of hCG in urine to aid in early pregnancy detection. Intended for use by the general population (OTC) or at point-of-care sites (prescription).

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

• The Quik-Check Home Pregnancy Test Device (k012215)

Submission Summary (Full Text)

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

A. 510(k) Number:
k131236

B. Purpose for Submission:
New Device

C. Measurand:
Human chorionic gonadotropin (hCG)

D. Type of Test:
Qualitative chromatographic immunoassay

E. Applicant:
UCP Biosciences, Inc.

F. Proprietary and Established Names:
UCP Home Pregnancy Midstream Test
UCP Home Pregnancy Dip Card/Strip
UCP Home Pregnancy Cassette Test
UCP Pregnancy Dip Card/Strip
UCP Pregnancy Cassette Test

G. Regulatory Information:
1. Regulation section:
21 CFR § 862.1155, Human chorionic gonadotropin (hCG) Test System
2. Classification:
Class II

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3. Product code:
LCX, JHI

4. Panel:
Clinical Chemistry (75)

H. Intended Use:

1. Intended use(s):
See indications for use below.

2. Indication(s) for use:
UCP Home Pregnancy Cassette Test is rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The device is intended for Over the Counter Use Only.

UCP Home Pregnancy Dip Card/Strip is rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The device is intended for Over the Counter Use Only.

UCP Home Pregnancy Midstream Test is rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The device is intended for Over the Counter Use Only.

UCP Pregnancy Cassette Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The device is intended for Prescription Use Only including at point of care sites.

UCP Pregnancy Dip Card/Strip is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The device is intended for Prescription Use Only including at point of care sites.

3. Special conditions for use statement(s):
UCP Home Pregnancy Cassette Test, UCP Home Pregnancy Dip Card/Strip, and UCP Home Pregnancy Midstream Test are for Over-the-Counter use.

UCP Pregnancy Cassette Test and UCP Pregnancy Dip Card/Strip are for Prescription Use Only including at point of care sites.

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4. Special instrument requirements: None

I. Device Description:

UCP Home Pregnancy Tests and UCP Pregnancy Tests use nitrocellulose strips in Midstream, Dip Card/Strip, and Cassette test formats. The tests are lateral flow immunoassays that are conducted by immersing the test strips in urine specimen and observing the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Users are able to read tests results in 3 minutes.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Quik-Check Home Pregnancy Test

2. Predicate 510(k) number(s):

k012215

3. Comparison with predicate:

| Parameter | UCP Home Pregnancy Test, UCP Pregnancy Test | Quik-Check Home Pregnancy Test (Predicate Device) |
| --- | --- | --- |
| Indications for Use | For the qualitative detection of hCG in urine to aid in the early detection of pregnancy. | Same |
| Intended Population | Over-the Counter and Prescription Use | Over-the-Counter Use |
| Format | Midstream, Dip Card/Strip, and Cassette | Strip, Cassette |
| Test Principle | Chromatographic immunoassay, lateral flow | Same |
| Test Time | 3 minutes | Same |
| Sensitivity | 25 mIU/mL | Same |

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| Standardization | WHO Fourth International Standard | WHO Third International Standard |
| --- | --- | --- |

## K. Standard/Guidance Document Referenced (if applicable):

Guidance for Industry and FDA Reviewers/Staff – Guidance for Over the Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s.

## L. Test Principle:

UCP Home Pregnancy Test and UCP Pregnancy Test use nitrocellulose strips. The test utilizes a mixture of monoclonal (mouse) and polyclonal (goat) antibodies to selectively identify the elevated level of hCG in human urine. A colloidal gold conjugate is used to visualize the immunological reaction. The assay is conducted by immersing the test strips in a urine specimen and observing the formation of colored lines. The urine specimen migrates via capillary action along the membrane to react with the colored conjugate. A negative specimen produces no line in the test zone (T), and one colored line in the control zone (C). A positive specimen produces distinct colored lines in both the test zone (T) and the control zone (C). An invalid specimen produces either no lines or one line in the test zone (T) and no line in the control zone (C).

## M. Performance Characteristics (if/when applicable):

### 1. Analytical performance:

#### a. Precision/Reproducibility:

The precision/reproducibility study was conducted at three sites (one internal site and 2 POC sites) using three lots by three operators over multiple days, with 20 replicates for each standard tested (0, 12.5, 18.75, 25, 31.25, 50, 100 mIU/mL hCG). Standards used for spiking contain the purified intact hCG traceable to the WHO International 4th Standard. The testing results are summarized in the following:

Pregnancy DipCard/Strip

| HCG Concentration (mIU/mL) | Total Numbers of Determinations | Lot#: A | Lot#:B | Lot#:C |
| --- | --- | --- | --- | --- |
| | | Results #Neg/# Pos | Results #Neg/#Pos | Results #Neg/#Pos |
| 0 | 20 | 20/0 | 20/0 | 20/0 |
| 12.5 | 20 | 20/0 | 20/0 | 20/0 |
| 18.75 | 20 | 18/2 | 20/0 | 19/1 |
| 25 | 20 | 0/20 | 0/20 | 0/20 |
| 31.25 | 20 | 0/20 | 0/20 | 0/20 |
| 50 | 20 | 0/20 | 0/20 | 0/20 |
| 100 | 20 | 0/20 | 0/20 | 0/20 |

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Pregnancy Cassette

| HCG Concentration (mIU/mL) | Total Numbers of Determinations | Lot#: A | Lot#:B | Lot#:C |
| --- | --- | --- | --- | --- |
| | | Results #Neg/# Pos | Results #Neg/#Pos | Results #Neg/#Pos |
| 0 | 20 | 20/0 | 20/0 | 20/0 |
| 12.5 | 20 | 20/0 | 20/0 | 20/0 |
| 18.75 | 20 | 20/0 | 20/0 | 19/1 |
| 25 | 20 | 0/20 | 0/20 | 0/20 |
| 31.25 | 20 | 0/20 | 0/20 | 0/20 |
| 50 | 20 | 0/20 | 0/20 | 0/20 |
| 100 | 20 | 0/20 | 0/20 | 0/20 |

Pregnancy Midstream

| HCG Concentration (mIU/mL) | Total Numbers of Determinations | Lot#: A | Lot#:B | Lot#:C |
| --- | --- | --- | --- | --- |
| | | Results #Neg/# Pos | Results #Neg/#Pos | Results #Neg/#Pos |
| 0 | 20 | 20/0 | 20/0 | 20/0 |
| 12.5 | 20 | 20/0 | 20/0 | 20/0 |
| 18.75 | 20 | 20/0 | 20/0 | 19/1 |
| 25 | 20 | 0/20 | 0/20 | 0/20 |
| 31.25 | 20 | 0/20 | 0/20 | 0/20 |
| 50 | 20 | 0/20 | 0/20 | 0/20 |
| 100 | 20 | 0/20 | 0/20 | 0/20 |

b. Linearity/assay reportable range:

Not applicable. The assay is intended for qualitative use.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

The tests are calibrated with reference material traceable to the World Health Organization (W.H.O.) 4th International Standard for Chorionic Gonadotropin (75/589).

The stability testing protocol and acceptance criteria used to support the shelf life were reviewed and found to be acceptable. The sponsor claims a 24 month shelf life from manufacturing date when stored at room temperature, 15-28°C (59-82°F).

d. Detection limit:

The detection limit is 25 mIU/mL. See "Precision/Reproducibility" M.1.a for test results summary.

e. Analytical specificity:

The analytical specificity was conducted by spiking Luteinizing Hormone (500

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mIU/mL), Follicle Stimulating Hormone (1000 mIU/mL) and Thyroid Stimulating Hormone (1000 mIU/mL) separately into urine samples that contain 0 and 25 mIU/mL hCG. The samples were tested by all device formats. The results demonstrate that the tested levels of LH, FSH, or TSH do not cross react with UCP Pregnancy tests.

The hCG β core fragment at the concentrations 250,000 pmol/L, 500,000 pmol/L, 1,000,000 pmol/L, respectively, was spiked into negative urine, urine samples that contain 0 and 25 mIU/mL hCG, then tested using 3 lots of each UCP Pregnancy test device formats. The results demonstrate that the hCG β core fragment does not interfere with UCP Pregnancy tests.

Various prescription, over the counter drugs, and chemicals (at a concentration of 100 ug/mL or above) and potential endogenous interferents were tested by each UCP Pregnancy Test format and showed no cross-reactivity with urine samples containing 0 and 25 mIU/mL hCG. The testing results are summarized in the following:

| Interfering substance | Concentration |
| --- | --- |
| Acetaminophen | 100ug/ml |
| Acetone | 100ug/ml |
| Albumin | 100ug/ml |
| Ampicillin | 100ug/ml |
| Ascorbic Acid | 100ug/ml |
| Aspartame | 100ug/ml |
| Aspirin | 100ug/ml |
| Atropine | 100ug/ml |
| Benzocaine | 100ug/ml |
| Bilirubin | 100ug/ml |
| Caffeine | 100ug/ml |
| Chloroquine | 100ug/ml |
| (+)-Chlorpheniramine | 100ug/ml |
| (+/-)-Chlorpheniramine | 100ug/ml |
| Creatine | 100ug/ml |
| Dexbrompheniramine | 100ug/ml |
| Dextromethorphan | 100ug/ml |
| Diphenhydramine | 100ug/ml |
| Dopamine | 100ug/ml |
| (+/-)-Epinephrine | 100ug/ml |
| Erythromycin | 100ug/ml |
| Ethanol | 100ug/ml |
| Furosemide | 100ug/ml |
| Glucose | 100ug/ml |
| Guaiacol Glycervl Ether | 100ug/ml |
| Hemoglobin | 100ug/ml |
| Ibuprofen | 100ug/ml |
| (+/-)-Isoproterenol | 100ug/ml |
| Ketamine | 100ug/ml |
| Levorphanol | 100ug/ml |

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| Lidocaine | 100ug/ml |
| --- | --- |
| (+)-Naproxen | 100ug/ml |
| Niacinamide | 100ug/ml |
| Nicotine | 100ug/ml |
| (+/-)-Norephedrine | 100ug/ml |
| Oxalic Acid | 100ug/ml |
| Penicillin-G | 100ug/ml |
| Pheniramine | 100ug/ml |
| Phenothiazine | 100ug/ml |
| 1-Phenylephrine | 100ug/ml |
| β-Phenylethylamine | 100ug/ml |
| Procaine | 100ug/ml |
| Quinidine | 100ug/ml |
| Ranitidine | 100ug/ml |
| Riboflavin | 100ug/ml |
| Sodium Chloride | 100ug/ml |
| Sulindac | 100ug/ml |
| Theophylline | 100ug/ml |
| Tyramine | 100ug/ml |
| 4-Dimethylaminoantipyrine | 100ug/ml |
| (1R,2S)-(-)-N-Methyl-Ephedrine | 100ug/ml |
| Albumin | 5 mg/ml |
| Bilirubin | 50mg/L |
| Creatine | 200mg/dl |
| Hemoglobin | 50 mg/L |
| Glucose | 500mg/ml |
| Vitamin(L-Ascorbic Acid) | 50mg/ml |
| Uric Acid | 8mg/dl |

To evaluate potential interference of urine pH on the test results, negative and positive urine samples (with hCG at 0 and 25 mIU/mL, respectively) were adjusted to pH ranges from 4.5 to 9, then tested by each UCP Pregnancy Test format. The results demonstrate urine pH ranging from 4.5 to 9 does not interfere with UCP Pregnancy Tests.

To evaluate potential interference of urine specific gravity on the test results, negative and positive urine samples (with hCG at 0 and 25 mIU/mL, respectively) were adjusted to the specific gravity values from 1.002 to 1.035, using unaltered urine as a control, and then tested by each UCP Pregnancy Test format. The results demonstrate urine specific gravity values from 1.002 to 1.035 do not interfere with UCP Pregnancy Tests.

f. Assay cut-off:

See detection limit section M.1.d.

2. Comparison studies:

a. Method comparison with predicate device:

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Comparison studies between each UCP Pregnancy Test format and the predicate device were conducted at a physician's office by lab professionals using 100 masked randomized urine specimens. The urine specimens were collected from 100 women who fit the following categories: childbearing age, suspected pregnant women, and women in early pregnancy (first trimester of pregnancy). The women collected urine samples in cups to be used for this study. The results of all formats of UCP Pregnancy Tests and the predicate device were 100% in agreement when tested by the lab professionals. The UCP Pregnancy Dip Card/Strip and Cassette contains the same test strip for home use and prescription use versions and identical testing results were obtained for each version. The testing results from lab professionals are summarized in the following:

UCP Home Pregnancy Midstream (Dip Method) vs. Predicate Device

| | Positive by Predicate | Negative by Predicate |
| --- | --- | --- |
| Positive by UCP Home Pregnancy Midstream | 49 | 0 |
| Negative by UCP Home Pregnancy Midstream | 0 | 51 |

UCP Pregnancy Dip Card/Strip (Home and Prescription use versions) vs. Predicate Device

| | Positive by Predicate | Negative by Predicate |
| --- | --- | --- |
| Positive by UCP Pregnancy Dip Card/Strip | 49 | 0 |
| Negative by UCP Pregnancy Dip Card/Strip | 0 | 51 |

UCP Pregnancy Cassette (Home and Prescription use versions) vs. Predicate Device

| | Positive by Predicate | Negative by Predicate |
| --- | --- | --- |
| Positive by UCP Pregnancy Cassette | 49 | 0 |
| Negative by UCP Pregnancy Cassette | 0 | 51 |

Lay-user studies were also conducted. Each UCP Home Pregnancy Test format was tested by lab professionals and each UCP Home Pregnancy Test format was tested by lay users. For the Midstream Test format study, each of 100 lay users tested their own midstream urine using the UCP Home Pregnancy Midstream test in addition to collecting the urine specimen in a cup for professional testing. Before testing, the lay users were given the Test Instructions (English) to read. The results of all formats of

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the UCP Home Pregnancy Tests performed by lay users and the results from all formats of the UCP Home Pregnancy Tests performed by lab professionals were 100% in agreement. The testing results are summarized in the following:

UCP Home Pregnancy Midstream Test

| | Positive by Lay Users | Negative by Lay Users |
| --- | --- | --- |
| Positive by Professionals | 49 | 0 |
| Negative by Professionals | 0 | 51 |

UCP Home Pregnancy Dip Card/Strip

| | Positive by Lay Users | Negative by Lay Users |
| --- | --- | --- |
| Positive by Professionals | 49 | 0 |
| Negative by Professionals | 0 | 51 |

UCP Home Pregnancy Cassette Test

| | Positive by Lay Users | Negative by Lay Users |
| --- | --- | --- |
| Positive by Professionals | 49 | 0 |
| Negative by Professionals | 0 | 51 |

Lay users participating in the study represented a diversity of age and various educational backgrounds. When the testing was complete, the users were asked to complete a questionnaire. The post-study survey indicated the lay users understood the test instructions, the meaning of the test results and can perform the test satisfactorily by following the test instruction. A Flesh-Kincaid reading analysis was performed on the test instructions and the score revealed a read grade level of 7.

b. Matrix comparison:

Not applicable

3. Clinical studies:

a. Clinical Sensitivity:

Not Applicable

b. Clinical specificity:

Not Applicable

c. Other clinical supportive data (when a. and b. are not applicable):

Not Applicable

4. Clinical cut-off:

Not Applicable

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5. Expected values/Reference range:

Not Applicable

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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