FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS

K112101 · Polymed Therapeutics, Inc. · JHI · Jul 17, 2012 · Clinical Chemistry

Device Facts

• Record ID: K112101
• Device Name: FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS
• Applicant: Polymed Therapeutics, Inc.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Jul 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Indications for Use

The Polymed Therapeutics' Fastep™ hCG Pregnancy Serum/Urine Test is rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in serum or urine specimen to aid in the early detection of pregnancy. For Professional Use Only. The test kits are for health care professionals use including professionals at physician's office labs (POLs) or point-of-care site (POC).

Device Story

Fastep™ hCG Pregnancy Serum/Urine Test is a rapid chromatographic immunoassay; utilizes cassette format. Input: serum or urine specimen. Principle: membrane coated with mouse monoclonal anti-a-hCG antibody; dried chemical pad contains mouse monoclonal anti-B-hCG antibody colloidal gold conjugate. Control line uses goat anti-mouse IgG. Operation: healthcare professional applies specimen to cassette; visual qualitative result (presence/absence of hCG) appears on test strip. Sensitivity: 20 mIU/mL. Used in POLs and POC sites. Output: visual color change indicating pregnancy status. Benefit: rapid, early pregnancy detection for clinical decision-making.

Clinical Evidence

Bench testing only. Reproducibility study conducted at 3 POC sites by 9 HCPs using 3 lots; 100% agreement for most concentrations, 96.9% at 20 mIU/mL cutoff. Analytical sensitivity confirmed 20 mIU/mL cutoff. Method comparison study (N=145) against predicate showed high concordance (Urine: 100% PPA/NPA; Serum: 98.3% PPA, 100% NPA). No clinical data required.

Technological Characteristics

Lateral flow sandwich immunochromatographic assay. Uses colloidal gold conjugate and monoclonal anti-hCG antibodies. Cassette format. Qualitative visual readout. Standardized to WHO 4th International Standard 75/589. No electronic components or software.

Indications for Use

Indicated for professional use in physician's office labs (POLs) or point-of-care (POC) settings for the qualitative detection of hCG in serum or urine to aid in early pregnancy detection.

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 Urine/Serum Combo Pregnancy Test (k964461)

Submission Summary (Full Text)

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

A. 510(k) Number:
k112101

B. Purpose for Submission:
New device

C. Measurand:
Human Chorionic Gonadotropin (hCG)

D. Type of Test:
Qualitative chromatographic immunoassay

E. Applicant:
Polymed Therapeutics, Inc.

F. Proprietary and Established Names:
Fastep hCG Pregnancy Serum/Urine Cassette Test

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JHI | 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:

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The Polymed Therapeutics Fastep™ hCG Pregnancy Serum/Urine Cassette Tests is a rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in serum or urine specimen to aid in the early detection of pregnancy. For professional use only.

3. Special conditions for use statement(s):

The Polymed Therapeutics Fastep™ hCG Pregnancy Serum/Urine Cassette Test is intended for prescription use (clinical laboratory, Point of Care (POC) and physician's office laboratory (POL) use).

The test kits are for health care professionals use including professionals at physician's office labs (POLs) and Point-of-care sites (POC).

4. Special instrument requirements:

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

I. Device Description:

The Fastep™ hCG Pregnancy Serum/Urine Test is a rapid test to detect the presence of hCG in serum or urine specimens in a qualitative format as an aid in the early detection of pregnancy. The test is available in a cassette format.

Devices are packaged one device per pouch and should be used immediately after opening.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Test

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

k964461

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Rapid qualitative detection of hCG to aid in the early detection of pregnancy. For POLs settings. | Same |
| Specimen type | Urine or serum | Same |

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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Test Principle | Lateral flow sandwich Immunochromatographic assay | Same |
| Detection reagent | Colloidal Gold | Same |
| Read time | Serum: 5 minutes
Urine: 3 minutes | Same |
| Specificity | Negative at:
hFSH: 1000mIU/mL
hTSH: 1000 uIU/mL | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Cutoff | 20 mIU/ml | 25 mIU/ml |
| Specificity | No effect from: hLH: 300 mIU/ml | No effect from: hLH: 500 mIU/ml |

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

Not applicable

## L. Test Principle:

The Polymed Therapeutics Fastep™ hCG Pregnancy Serum/Urine Cassette Tests is a qualitative, lateral flow sandwich immunochromatographic assay for the detection of human chorionic gonadotropin (hCG) in serum and urine. The membrane is pre-coated with monoclonal anti-hCG antibodies on the test band region and anti-mouse antibodies in the control band region. During testing, the sample reacts with the dye conjugate (mouse anti-hCG antibody-colloidal gold conjugate) which has been pre-coated on the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action to react with anti-hCG antibodies on the membrane and generate a colored line. One colored line appears in the control region “C” regardless of the presence of hCG. The presence of this colored line in the “C” region serves as verification for sufficient volume and proper flow and as a control for the reagents. The absence of the test line in the “T” region indicates a negative result. Two colored lines should be observed in the viewing window at the “C” and “T” regions in order to indicate a positive result. No line in the “C” region will indicate that the test is invalid and needs to be repeated.

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

1. Analytical performance:

a. Precision/Reproducibility:

A Point of Care (POC) study was conducted to evaluate the reproducibility of the

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device by the intended operators. The study was conducted at 3 healthcare POC sites by 9 healthcare professionals (HCPs) (3 operators per site). 3 different lots (one lot per site) were used for the study. The reproducibility of the device was evaluated by testing negative urine and serum samples spiked with hCG, traceable to WHO International $4^{\text{th}}$ Standard, $(0\mathrm{mIU/ml}, 10\mathrm{mIU/ml}, 15\mathrm{mIU/ml}, 20\mathrm{mIU/ml}, 40\mathrm{mIU/ml}$ and $100\mathrm{mIU/ml})$ . All samples were blinded to the HCPs. Each concentration level was tested 5 times a day for 5 consecutive days. The results are summarized below:

Urine:

| hCG levels (mIU/ml) | Total No. Tested | % Agreement | Site 1 | | Site 2 | | Site 3 | | Total Results | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | (+) | (-) | (+) | (-) | (+) | (-) | (+) | (-) |
| 0 | 225 | 100 | 0 | 75 | 0 | 75 | 0 | 75 | 0 | 225 |
| 10 | 225 | 100 | 0 | 75 | 0 | 75 | 0 | 75 | 0 | 225 |
| 15 | 225 | 100 | 0 | 75 | 0 | 75 | 0 | 75 | 0 | 225 |
| 20 | 225 | 96.9 | 71 | 4 | 74 | 1 | 73 | 2 | 218 | 7 |
| 40 | 225 | 100 | 75 | 0 | 75 | 0 | 75 | 0 | 225 | 0 |
| 100 | 225 | 100 | 75 | 0 | 75 | 0 | 75 | 0 | 225 | 0 |

Serum:

| hCG levels (mIU/ml) | Total No. Tested | No. Tested per site | Site 1 | | Site 2 | | Site 3 | | Total Results | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | (+) | (-) | (+) | (-) | (+) | (-) | (+) | (-) |
| 0 | 225 | 100 | 0 | 75 | 0 | 75 | 0 | 75 | 0 | 225 |
| 10 | 225 | 100 | 0 | 75 | 0 | 75 | 0 | 75 | 0 | 225 |
| 15 | 225 | 100 | 0 | 75 | 0 | 75 | 0 | 75 | 0 | 225 |
| 20 | 225 | 96.9 | 72 | 3 | 73 | 2 | 73 | 2 | 218 | 7 |
| 40 | 225 | 100 | 75 | 0 | 75 | 0 | 75 | 0 | 225 | 0 |
| 100 | 225 | 100 | 75 | 0 | 75 | 0 | 75 | 0 | 225 | 0 |

# b. Linearity/assay reportable range:

Linearity is not applicable since this is a qualitative test.

A high dose hook effect study was performed by spiking high levels of hCG concentrations 0-1,000,000 mIU/ml (0, 10, 20, 100, 62,500, 125,000, 250,000, 500,000 and 1,000,000) into negative urine and serum samples and evaluating the test result lines. A positive result was observed up to 1,000,000 mIU/ml. Therefore no hook effect was observed for urine/serum samples with hCG concentrations up to 1,000,000 mIU/ml.

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

The Polymed Therapeutics Fastep™ hCG Pregnancy Serum/Urine Cassette and Dipstick Test is standardized to the WHO Fourth International Standard 75/589

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A shelf-life stability test of the device was performed in real-time and the results showed that the device is stable for 24 months when stored at 2-8°C or room temperature (up to 30°C). This is a single use device and labeling states that test should be performed immediately after opening pouch.

d. Detection limit:

The sensitivity of the device was tested by spiking pooled male urine and serum with varying concentrations (0, 10, 12.5, 15.0, 17.5, 20, 24, 30.0, 35.0, 40, and 100 mIU/mL) of hCG traceable to WHO International 4th Standard. Three separate lots of the device were tested in house using randomization methods. Results are summarized below.

All 3 lots combined (Urine samples):

| Urine Controls hCG Levels (mIU/ml) | Number Tested | Number of Negative | Number of Positive | % Negative | % Positive |
| --- | --- | --- | --- | --- | --- |
| 0 | 75 | 75 | 0 | 100 | 0 |
| 10.0 | 75 | 75 | 0 | 100 | 0 |
| 12.5 | 75 | 69 | 6 | 92.0 | 8.0 |
| 15.0 | 75 | 36 | 39 | 48.0 | 52.0 |
| 17.5 | 75 | 6 | 69 | 8.0 | 92.0 |
| 20.0 | 75 | 0 | 75 | 0 | 100 |
| 24.0 | 75 | 0 | 75 | 0 | 100 |
| 30.0 | 75 | 0 | 75 | 0 | 100 |
| 35.0 | 75 | 0 | 75 | 0 | 100 |
| 40.0 | 75 | 0 | 75 | 0 | 100 |
| 100.0 | 75 | 0 | 75 | 0 | 100 |

All 3 lots combined (Serum samples):

| hCG Levels (mIU/ml) | Number Tested | Number of Negative | Number of Positive | % Negative | % Positive |
| --- | --- | --- | --- | --- | --- |
| 0 | 75 | 75 | 0 | 100 | 0 |
| 10.0 | 75 | 75 | 0 | 100 | 0 |
| 12.5 | 75 | 64 | 11 | 85.3 | 14.7 |
| 15.0 | 75 | 37 | 38 | 49.3 | 50.7 |
| 17.5 | 75 | 7 | 68 | 9.3 | 90.7 |
| 20.0 | 75 | 0 | 75 | 0 | 100 |
| 24.0 | 75 | 0 | 75 | 0 | 100 |
| 30.0 | 75 | 0 | 75 | 0 | 100 |
| 35.0 | 75 | 0 | 75 | 0 | 100 |
| 40.0 | 75 | 0 | 75 | 0 | 100 |
| 100.0 | 75 | 0 | 75 | 0 | 100 |

The sponsor claims a cutoff for positive as 20mIU/mL.

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# e. Analytical specificity:

i.) A cross-reactivity study was performed by adding known amounts of LH, FSH and TSH to pooled negative urine and serum samples. Samples were tested in duplicate. Samples were tested at 0 and $20\mathrm{mIU / ml}$ of hCG. The cross-reactivity results are shown below:

Urine hCG:

| Concentration (IU/ml) | HCG 0 mIU/ml | | HCG 20 mIU/ml | |
| --- | --- | --- | --- | --- |
| | Result 1 | Result 2 | Result 1 | Result 2 |
| LH 300 mIU/mL | (-) | (-) | (+) | (+) |
| FSH 1000 mIU/mL | (-) | (-) | (+) | (+) |
| TSH 1000 μIU/ml | (-) | (-) | (+) | (+) |

Serum hCG

| Concentration (IU/ml) | HCG 0 mIU/ml | | HCG 20 mIU/ml | |
| --- | --- | --- | --- | --- |
| | Result 1 | Result 2 | Result 1 | Result 2 |
| LH 300 mIU/mL | (-) | (-) | (+) | (+) |
| FSH 1000 mIU/mL | (-) | (-) | (+) | (+) |
| TSH 1000 μIU/ml | (-) | (-) | (+) | (+) |

No cross-reactivity was observed for either urine or serum samples at the concentrations that were tested for LH, FSH and TSH.

ii.) An interference study was performed by adding known amounts of potential interfering substances to urine and serum samples that contain 0 and $20\mathrm{mIU / mL}$ of hCG. The sponsor states that none of the following substances at the stated concentrations interfere with the assay.

Urine Samples:

| Interfering substance | Concentration |
| --- | --- |
| Acetaminophen | 20 mg/dl |
| Acetylsalicylic Acid | 20 mg/dl |
| Albumin | 2000 mg/dl |
| Ascorbic Acid | 20 mg/dl |
| Atropine | 20 mg/dl |
| Bilirubin | 2 mg/dl |
| Caffeine | 20 mg/dl |
| EDTA | 80 mg/dl |
| Ethanol | 1% |
| Gentenoic Acid | 20 mg/dl |
| Glucose | 2 g/dl |
| Hemoglobin | 1 mg/dl |
| Methanol | 1% |
| Salicylic Acid | 20 mg/dl |

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Serum Samples:

| Interfering substance | Concentration |
| --- | --- |
| Acetaminophen | 20 mg/dl |
| Acetylsalicylic Acid | 20 mg/dl |
| Albumin | 2000 mg/dl |
| Ascorbic Acid | 20 mg/dl |
| Atropine | 20 mg/dl |
| Bilirubin | 40 mg/dl |
| Caffeine | 20 mg/dl |
| EDTA | 80 mg/dl |
| Ethanol | 1% |
| Gentensic Acid | 20 mg/dl |
| Glucose | 2 g/dl |
| Hemoglobin | 125 mg/dl |
| Methanol | 1% |
| Salicylic Acid | 20 mg/dl |
| Triglyceride | 1200 mg/dl |

iii.) A pH study was performed to evaluate the device and the sponsor concluded that urine and serum samples with pH 3.0 – 8.5 would not affect the results.

iv.) A specific gravity study was performed to evaluate the device and the sponsor concluded that the performance of Fastep hCG Serum/Urine Pregnancy test at negative and cutoff points are not affected when the specific gravity range of urine specimens is at 1.00 to 1.03.

v.) Interference studies to β-core hCG were also performed; the results indicate there was no interference with β-core hCG up to 8.53 pmol/L

f. Assay cut-off:

See 1.d. above

2. Comparison studies:

a. Method comparison with predicate device:

A method comparison study was performed comparing the Fastep™ cassette panel to the Teco One-Step Combo Card Test (predicate device). Testing was conducted by one HCP at 4 POC sites. 19-46 individuals per site were enrolled in the study (N=145). The samples were collected from women who fit the following categories: childbearing age, suspected pregnant women, (e.g. within days of missing the expected menses), women early in pregnancy, (e.g. within the first 30 days of pregnancy), and the first trimester of pregnancy. All samples were masked prior to analysis. Testing was performed according to the labeling.

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Urine:

| Fastep™ Cassette Panel | Teco One-Step Combo Card Test (predicate kit) | | | |
| --- | --- | --- | --- | --- |
| | | + | - | Total |
| | + | 59 | 0 | 59 |
| | - | 0 | 86 | 86 |
| | Total | 59 | 86 | 145 |

Serum:

| Fastep™ Cassette Panel | Teco One-Step Combo Card Test(Predicate Kit) | | | |
| --- | --- | --- | --- | --- |
| | | + | - | Total |
| | + | 58 | 0 | 58 |
| | - | 1 | 86 | 87 |
| | Total | 59 | 86 | 145 |

b. Matrix comparison:

This test is only applicable to urine or serum samples. Performance with both of these matrices is described in the performance sections above.

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:

The labeling states "Negative results are expected in healthy non-pregnant women" The amount of hCG will vary greatly with gestational age and between individuals."

The telephone number of the distributor has been provided in the labeling for technical assistance.

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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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