FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER

K122907 · Polymed Therapeutics, Inc. · LCX · Mar 14, 2013 · Clinical Chemistry

Device Facts

• Record ID: K122907
• Device Name: FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER
• Applicant: Polymed Therapeutics, Inc.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Mar 14, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The Polymed Therapeutics' Fastep™ At-home Pregnancy Test is a rapid chromatographic immunoassay for the visual, qualitative detection of human chorionic gonadotropin (hCG) in urine specimen to aid in the early detection of pregnancy. Polymed Therapeutics' Fastep™ At-Home Pregnancy Test is intended to be distributed for Over-the-Counter (OTC) use.

Device Story

Fastep™ At-Home Pregnancy Test is a rapid chromatographic immunoassay for qualitative hCG detection in urine. Device consists of a test strip in plastic housing with an absorbent tip. Principle of operation: lateral flow immunoassay using mouse monoclonal anti-a-hCG antibody coated membrane and dried mouse monoclonal anti-ß-hCG antibody colloidal gold conjugate; control line uses goat anti-mouse IgG. User immerses absorbent tip in urine stream or cup. Results are visual; presence of hCG indicated by color development. Used in home setting by lay users. Provides early pregnancy determination. Benefits include ease of use and interpretation for consumers.

Clinical Evidence

Two lay user studies conducted. Study 1: 129 users tested midstream and dipstick modes; results compared to predicate. Dipstick mode: 58/62 positive, 85/85 negative. Midstream mode: 51/55 positive, 72/72 negative. Discrepancies resolved via quantitative serum hCG (Abbott Architect i2000), confirming negative status. Study 2: 21 users tested masked samples at 16.7, 25.3, and 38.7 mIU/mL; 100% agreement with expected results at 25.3 and 38.7 mIU/mL. >97% of users reported instructions were easy to understand.

Technological Characteristics

Lateral flow sandwich immunochromatographic assay. Components: mouse monoclonal anti-α-hCG antibody coated membrane, mouse monoclonal anti-β-hCG colloidal gold conjugate, goat anti-mouse IgG control. Format: midstream and dipstick. Cutoff: 20 mIU/mL. Traceability: WHO 4th International Standard. Storage: 35–86°F. No instrumentation required.

Indications for Use

Indicated for qualitative detection of hCG in urine to aid in early pregnancy detection. Intended for over-the-counter (OTC) use by lay users.

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

• Teco Diagnostics One-Step Midstream Pregnancy Test (k974059)

Submission Summary (Full Text)

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

A. 510(k) Number:
k122907

B. Purpose for Submission:
Addition of over-the counter claim

C. Measurand:
Human Chorionic Gonadotropin (hCG)

D. Type of Test:
Qualitative chromatographic immunoassay

E. Applicant:
Polymed Therapeutics, Inc.

F. Proprietary and Established Names:
Fastep™ At-Home Pregnancy Test

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| LCX | Class II | 21 CFR 862.1155, Human Chorionic Gonadotropin (hCG) test system | 75 Clinical Chemistry (CH) |

H. Intended Use:

1. Intended use(s):
See Indications for Use below

2. Indication(s) for use:
The Polymed Therapeutics' Fastep™ At-home Pregnancy Test is a rapid chromatographic immunoassay for the visual, qualitative detection of human chorionic gonadotropin (hCG) in urine specimen to aid in the early detection of pregnancy.

Polymed Therapeutics' Fastep™ At-Home Pregnancy Test is intended to be distributed

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for Over-the-Counter (OTC) use.

3. Special conditions for use statement(s):

Intended for OTC use.

4. Special instrument requirements:

None, this device is a visually-read, single-use device.

I. Device Description:

The Fastep™ At-Home Pregnancy Test is designed to be tested in midstream and dipstick mode. The Fastep™ At-Home Pregnancy Test consists of a single test strip encased in plastic device housing, with an absorbent tip. The result is generated by immersing the tip in the urine stream or urine cup for a sufficient amount of time to absorb an adequate sample volume. Each test reagent strip consists of a mouse monoclonal anti-α-hCG antibody coated membrane and a dried chemical pad containing mouse monoclonal anti-β-hCG anybody colloidal gold conjugate. The control antibodies are goat anti-mouse IgG.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Teco Diagnostics One-Step Midstream Pregnancy Test

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

k974059

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| | Candidate Device | Predicate Device |
| Intended Use | Rapid qualitative detection of hCG to aid in the early detection of pregnancy. | Same |
| Target User | Over-the-Counter Use | Same |
| Specimen | Urine | Same |
| Test Principle | Lateral flow Sandwich Immunochromatographic Assay | Same |
| Positive result | 2 colored lines | Same |
| Negative result | 1 colored line | Same |
| Detection reagent | Colloidal gold | Same |
| Storage | 35 – 86°F (2 – 30°C) | Same |

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| Differences | | |
| --- | --- | --- |
| Item | Candidate Device | Predicate Device |
| Cutoff | 20 mIU/ml | 25 mIU/ml |
| Device Format | Midstream and Dipstick mode | Midstream mode |
| Read time | 3 to 5 minutes | 5 minutes (Do not read result after more than 30 minutes) |
| Traceability | WHO 4th International Standard | WHO 3rd International Standard |

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

Not applicable

L. Test Principle:

The Polymed Therapeutics Fastep™ At-Home Pregnancy Tests is a qualitative, lateral flow sandwich immunochromatographic assay for the detection of human chorionic gonadotropin (hCG) in urine.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

See 510(k) decision summary for k112101

b. Linearity/assay reportable range:

See 510(k) decision summary for k112101

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

See 510(k) decision summary for k112101

d. Detection limit:

See 510(k) decision summary for k112101

e. Analytical specificity:

See 510(k) decision summary for k112101

f. Assay cut-off:

See 510(k) decision summary for k112101

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2. Comparison studies:

a. Method comparison with predicate device:

The sponsor has submitted two studies to demonstrate performance in the hands of lay users:

In the first lay user study, 129 lay users self-tested using both midstream and dipstick mode, and 19 lay users tested urine samples in dipstick mode only. All lay users were instructed to read the proposed package insert (in English) to operate the device. Each lay user was also given a questionnaire to rate how well they understood the instructions. More than 97% of lay users agreed that the user instruction was written in a manner that was easy to use and understand.

Lay users' results with the new test were compared to professionals' results using the OTC predicate test (Teco Diagnostics One-Step Midstream Pregnancy Test k974059) and the results are summarized below:

1) Dipstick Mode comparison

| Fastep™
At-Home
Test(Dipstick) | Teco Diagnostics | | | |
| --- | --- | --- | --- | --- |
| | | + | - | Total |
| | + | 58 | 0 | 58 |
| | - | 4* | 85 | 89 |
| | Total | 62 | 85 | 147** |

* Paired serum samples were also collected from each lay-user for quantitative hCG measurement (Abbott Architect i2000). The observed values from the serum results for these 4 samples were negative.
**One "invalid" result was obtained using predicate device; therefore, only 147 dipstick mode results were tabulated.

2) Midstream Mode comparison

| Fastep™
At-Home
Test(Midstream) | Teco Diagnostics | | | |
| --- | --- | --- | --- | --- |
| | | + | - | Total |
| | + | 51 | 0 | 51 |
| | - | 4* | 72 | 76 |
| | Total | 55 | 72 | 127** |

* Paired serum samples were also collected from each lay-user for quantitative hCG measurement (Abbott Architect i2000). The observed values from the serum results for these 4 samples were negative.
**One "invalid" result was obtained for midstream mode using predicate device and candidate device, respectively; therefore only 127 midstream mode results were tabulated.

In the second lay user study, 21 lay users were recruited to test masked, randomized urine samples in dipstick mode with hCG concentrations close to the cutoff level at 16.7, 25.3

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and 38.7 mIU/mL. Each lay user tested 3 blinded samples using package insert instructions only. The lay user study results are summarized below:

| hCG concentration | Lay user results |
| --- | --- |
| 16.7 mIU/mL | 21/21 negative |
| 25.3 mIU/mL | 21/21 positive |
| 38.7 mIU/mL | 21/21 positive |

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

5. Expected values/Reference range:

N. Proposed Labeling:

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

O. Conclusion:

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