FASTEP S10 HCG SERUM/URINE COMBO TEST

K132834 · Polymed Therapeutics, Inc. · JHI · Jan 9, 2014 · Clinical Chemistry

Device Facts

• Record ID: K132834
• Device Name: FASTEP S10 HCG SERUM/URINE COMBO TEST
• Applicant: Polymed Therapeutics, Inc.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Jan 9, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The Fastep S10 hCG Serum/Urine Combo Test is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionic gonadotropin in human urine or serum specimens. This kit is intended for use as an aid in early detection of pregnancy. This product is only intended for prescription use in clinical laboratories and is not intended for point-of-care use settings.

Device Story

The Fastep S10 hCG Serum/Urine Combo Test is a lateral flow chromatographic immunoassay for the qualitative detection of hCG in human urine or serum. The device utilizes a strip or cassette format containing a membrane pre-coated with goat anti-hCG polyclonal antibody and an antibody-dye conjugate (mouse anti-beta hCG monoclonal antibody). When the absorbent end is immersed in a specimen, capillary action draws the sample across the membrane. If hCG is present at or above the cutoff (10 mIU/mL for serum, 20 mIU/mL for urine), a colored test line forms. A control line indicates valid test performance. The device is intended for use by clinical laboratory professionals. Results are visually interpreted by the clinician to aid in the early detection of pregnancy. The test provides a rapid, presumptive diagnosis, assisting in clinical decision-making regarding pregnancy status.

Clinical Evidence

Bench testing only. Method comparison study performed with 100 urine and 100 serum samples from 100 women, comparing candidate device to predicate. Results showed high agreement across all formats (strip/cassette). Analytical performance included precision/reproducibility studies across 3 lots, 3 operators, and 5 days. Specificity testing confirmed no cross-reactivity with LH, FSH, or TSH. Interference studies evaluated various exogenous compounds, pH, and specific gravity. High-dose hook effect testing showed no interference up to 2,000,000 mIU/mL hCG.

Technological Characteristics

Lateral flow sandwich immunochromatographic assay. Formats: strip and cassette. Detection reagent: colloidal gold. Cut-off: 10 mIU/mL (serum), 20 mIU/mL (urine). Storage: 4-30°C. Shelf life: 24 months. No electronic components or software.

Indications for Use

Indicated for the qualitative, presumptive detection of human chorionic gonadotropin (hCG) in human urine or serum to aid in the early detection of pregnancy. For prescription use in clinical laboratories only; not for point-of-care settings.

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

• QuickVue One-Step hCG Combo test (K020801)

Submission Summary (Full Text)

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K132834

JAN - 9 2014

## 510(k) SUMMARY

- December 20, 2013 1. Date: 2. Submitter: POLYMED THERAPEUTICS, INC. 3040 Post Oak Blvd Ste 1110 Houston, TX 77056 Contact person: Joe Shia 3: LSI International Inc. 504 East Diamond Ave., Suite F Gaithersburg, MD 20878 Telephone: [phone] Fax: [phone] Email:[e-mail]
- 4. Device Name:

Fastep S10 hCG Serum/Urine Combo Test

- Classification: Class II

| Product<br>Code | CFR # | Panel |
|-----------------|-------------------------------------------------------------|--------------------|
| JHI | 862.1155, Human chorionic<br>gonadotropin (HCG) test system | Clinical Chemistry |

- 5. Predicate Devices:
K020801, QuickVue One-Step hCG Combo test

## Quidel Corporation

- 6. Intended Use
The Fastep S10 hCG Serum/Urine Combo Test is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionic gonadotropin in human urine or serum specimens. This kit is intended for use as an aid in early detection of pregnancy.

This product is only intended for prescription use in clinical laboratories and is not intended for point-of-care use settings.

- 7. Device Description
Fastep S10 hCG Serum/Urine Combo Test measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine or serum for the early detection of pregnancy. During pregnancy, HCG is produced by the placenta shortly after the embryo attaches to the uterine lining. The test devices are in two different formats: Strip, Cassette.

- 8. Substantial Equivalence Information
A summary comparison of features of the Fastep S10 hCG Serum/Urine Combo Test and the predicate device is provided in the following table.

| Item | Device | Predicate |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Intended Use | Rapid qualitative detection of hCG<br>to aid in the early detection of<br>pregnancy. For prescription use in<br>clinical laboratories, not for POC | Same except that the<br>predicate can be used for<br>POC use settings. |

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| | | use. | |
|---------------------------|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------|--|
| Specimen | Urine or serum | Same | |
| Principle | Lateral flow Sandwich<br>Immunochromatographic Assay | Same | |
| Detection reagent | Colloidal gold | Same | |
| Read time | Serum: 5 minutes Urine: 3<br>minutes | Same | |
| Usage | For prescription use | Same | |
| Cut-Off Values | 10 mIU/mL for serum and 20<br>mIU/mL for urine | Same | |
| Configurations | Strip and cassette | Same | |
| Storage | 4 - 30°C | 15 - 30°C | |
| Reading Control<br>Window | 1 window for result reading and<br>control reading | 2 windows: Small Control<br>Window and Large Read<br>Result Window | |
| Read Result<br>Window | No preprinted line on membrane | Pre-printed horizontal<br>blue line on membrane | |
| Positive result | 2 colored red/pinkish horizontal<br>lines in control and test regions | Pink and blue plus sign<br>in large Window, along<br>with a blue line in small<br>Window | |
| Negative result | 1 colored line in control region only | Blue horizontal line in<br>Large Window, along<br>with a blue line in small<br>Window | |

## 9. Test Principle

It is a lateral flow chromatographic immunoassay. When the absorbent end is immersed into a sample, the sample is absorbed into the device by capillary action and mixes with the antibody-dye conjugate (mouse anti-beta HCG monoclonal antibody), flowing across the pre-coated (Goat anti HCG polyclonal antibody) membrane. At analyte concentration above the target cut off, it produces a colored test line that indicates a positive result. When analyte concentration is below the cutoff, no colored band shows in the test region, indicating a , negative result. No line in the "C" region indicates that the test is invalid.

#### 10. Performance Characteristics

- 1. Analytical Performance
- a. Precision/Reproducibility/Cut-Off Value

Negative serum specimens were spiked with varying hCG (commercially available and traceable to the 4th WHO international Standard) concentrations. The spiked samples were measured in 10 replicates using 3 different lots for each format. Tests were performed by

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three different operators for each lot in 2 runs per day for 5 days. Results are shown in the following tables.

| | Lot 1<br>HCG1203004 | | Lot 2<br>HCG1204001 | | Lot 3<br>HCG1204023 | | Overall<br>Agreement |
|----------------------------------|---------------------|------------------|---------------------|------------------|---------------------|------------------|----------------------|
| hCG<br>Concentration<br>(mIU/mL) | # of<br>negative | # of<br>positive | # of<br>negative | # of<br>positive | # of<br>negative | # of<br>positive | |
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 100% |
| 2 | 30 | 0 | 30 | 0 | 30 | 0 | 100% |
| 4 | 30 | 0 | 30 | 0 | 30 | 0 | 100% |
| 6 | 30 | 0 | 30 | 0 | 30 | 0 | 100% |
| 8 | 28 | 2 | 27 | 3 | 27 | 3 | 91% |
| 9 | 23 | 7 | 20 | 10 | 21 | 9 | 71% |
| 10 | 1 | 29 | 2 | 28 | 0 | 30 | 97% |
| 12 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |
| 14 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |
| 16 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |
| 18 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |
| 20 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |
| 100 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |
| 150 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |
| Serum Cassette format | | | | | | | |
| | Lot 1<br>HCG1212025 | | Lot 2<br>HCG1305011 | | Lot 3<br>HCG1306024 | | Overall<br>Agreement |
| hCG<br>Concentration<br>(mIU/mL) | # of<br>negative | # of<br>positive | # of<br>negative | # of<br>positive | # of<br>negative | # of<br>positive | |
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 100% |
| 2 | 30 | 0 | 30 | 0 | 30 | 0 | 100% |
| 4 | 30 | 0 | 30 | 0 | 30 | 0 | 100% |
| 6 | 30 | 0 | 30 | 0 | 30 | 0 | 100% |
| 8 | 27 | 3 | 28 | 2 | 26 | 4 | 90% |
| 9 | 24 | 6 | 21 | 9 | 22 | 8 | 74% |
| 10 | 1 | 29 | 1 | 29 | 2 | 28 | 96% |
| 12 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |
| 14 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |
| 16 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |
| 18 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |
| 20 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |
| 100 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |
| 150 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |
| hCG | Lot 1<br>HCG1203004 | | Lot 2<br>HCG1204001 | | Lot 3<br>HCG1204023 | | Overall<br>Agreement |
| Concentration<br>(mIU/mL) | # of<br>negative | # of<br>positive | # of<br>negative | # of<br>positive | # of<br>negative | # of<br>positive | |
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 100% |
| 5 | 30 | 0 | 30 | 0 | 30 | 0 | 100% |
| 10 | 30 | 0 | 30 | 0 | 30 | 0 | 100% |
| 12 | 30 | 0 | 30 | 0 | 30 | 0 | 100% |
| 14 | 30 | 0 | 30 | 0 | 30 | 0 | 100% |
| 16 | 25 | 5 | 28 | 2 | 26 | 4 | 88% |
| 18 | 21 | 9 | 19 | 11 | 19 | 11 | 66% |
| 20 | 1 | 29 | 2 | 28 | 1 | 29 | 96% |
| 22 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |
| 25 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |
| 30 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |
| 35 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |
| 75 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |
| 100 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |
| 250 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |

Serum Strip format

Negative urine specimens were spiked with varying hCG (commercially available and traceable to the 4th WHO international Standard) concentrations. The spiked samples were

:

:

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measured in 10 replicates using 3 different lots for each format. Tests were performed by three different operators for each lot in 2 runs per day for 5 days. Results are shown in the following tables.

## Urine Strip format

Urine Cassette format

| hCG | Lot 1<br>HCG1212025 | | Lot 2<br>HCG1305011 | | Lot 3<br>HCG1306024 | | Overall |
|---------------------------|---------------------|----------|---------------------|----------|---------------------|----------|-----------|
| Concentration<br>(mIU/mL) | # of | # of | # of | # of | # of | # of | Agreement |
| | negative | positive | negative | positive | negative | positive | |
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 100% |
| 5 | 30 | 0 | 30 | 0 | 30 | 0 | 100% |
| 10 | 30 | 0 | 30 | 0 | 30 | 0 | 100% |
| 12 | 30 | 0 | 30 | 0 | 30 | 0 | 100% |
| 14 | 30 | 0 | 30 | 0 | 30 | 0 | 100% |
| 16 | 24 | 6 | 26 | 4 | 22 | 8 | 80% |
| 18 | 19 | 11 | 17 | 13 | 15 | 15 | 57% |
| 20 | 1 | 29 | 0 | 30 | 1 | 29 | 98% |
| 22 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |
| 25 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |
| 30 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |
| 35 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |
| 75 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |
| 100 | 0 | 30 | 0 | 30 | 0 | 30 | 100% |

.

.

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| ------------------------------------------------------------------- | - | | And Children Children Charles Comments of Children | | |

Cut-off values of 10 mIU/mL for serum and 20 mIU/mL for urine are established.

## b. Stability

Stable at 4-30°C for 24 months based on the accelerated stability study at 50°C and real time stability determination at both 4°C and 30°C.

c. Specificity / Cross Reactivity

## High Dose Effect

Negative urine (serum) samples were spiked with varying high hCG concentrations. The spiked samples were tested by 3 different lots and 3 different operators. No hook effect Typical results are shown in the following table. was observed at these concentrations.

| hCG Concentration | Operator | Operator | Operator |
|-------------------|----------|----------|----------|
| (mIU/mL) | A | B | C |
| 62500 | + | + | + |
| 125000 | + | + | + |
| 250000 | + | + | + |
| 500000 | + | + | + |
| 1000000 | + | + | + |
| 2000000 | + | + | + |

### Effects of hCG B-core fragment

Serum samples with 0mlU/mL hCG and 10mIU/mL hCG were spiked with varying concentrations of B-core fragment hCG. These samples were tested by 3 different lots and 3 different operators. No difference was observed for different lots and different operators. Interference was observed at concentrations of 500 pmol/L and above for hCG free serum samples, and no interference was observed for serum samples spiked with 10mIUmL hCG. The same results were observed for urine samples with 0mIU/mL hCG and 20mIU/mL hCG.

| β-core fragment | Sample with | Serum Sample with | Urine Sample with |
|-----------------|-------------|-------------------|-------------------|
| hCG (pmol/L) | 0mIU/mL hCG | 10mIU/mL hCG | 20mIU/mL hCG |
| 0 | - | + | + |
| 10 | - | + | + |
| 20 | - | + | + |
| 50 | - | + | + |
| 100 | - | + | + |
| 200 | - | + | + |
| 500 | + | + | + |
| 1000 | + | + | + |
| 2000 | + | + | + |
| 5000 | + | + | + |
| 10000 | + | + | + |
| 20000 | + | + | + |
| 65000 | + | + | + |
| 100000 | + | + | + |
| 500000 | + | + | + |
| 1X10e6 | + | + | + |

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| 2X10e6 |
|--------|
|--------|

+

## Effects of glycoprotein LH, FSH and TSH

Negative and positive samples (0 and 20 mIU/mL hCG for urine, and 0 and 10 mIU/mL hCG for serum) were spiked with various concentrations of other glycoprotein hormones such as LH, FSH, and TSH. Samples were tested using three different lots by three operators. Typical results are shown in the following table.

| Negative Sample | Operator | Operator | Operator |
|--------------------------------|---------------|---------------|---------------|
| Spiked with | | 13 | |
| LH (300mlU/mL) | | | |
| FSH (1000mIU/mL) | | | |
| TSH (1000μIU/mL) | | | |
| Positive Sample<br>Spiked with | Operator<br>A | Operator<br>B | Operator<br>C |
| LH (300mlU/mL) | + | + | + |
| FSH (1000mlU/mL) | + | + | + |
| TSH (1000µIU/mL) | + | + | + |

## d. Interference

To evaluate potential interference from certain exogenous compounds, each interferent was made at 100X concentrate bulk and spiked in both hCG free and hCG positive (10mlU/mL for serum, 20mIU/mL for urine) samples. Each spiked urine sample was mixed for 5 minutes to ensure a homogeneous solution before testing. Each sample was tested using 3 different lots of the testing kit. Results are shown in the following table.

| | 3 minutes for urine (5 minutes for serum) | | | | | 10 minutes | | | | | | |
|--------------------------------|-------------------------------------------|------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|------|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|------|------|
| Interferents | 0mIU/mL hCG | | Positive bCG | | | 0ml U/mL hCG | | | Positive hCG | | | |
| | Lot} | Lot2 | Lot3 | Lot l | Lot2 | Lot3 | Lot l | Lot2 | Lot3 | Lot l | Lot2 | Lot3 |
| Acetaminophen (20mg/dL) | ﻠ | l | f | + | + | + | - | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | + | + | + |
| Acetoacetic Acid (2000mg/dL) | - | - | l | + | + | + | - | - | l | + | + | + |
| Asorbic Acid (20mg/dL) | -- | - | - | + | + | + | - | - | - | + | + | + |
| B-hydroxybutyrate (2000mg/dL) | - | l | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | + | + | + | - | - | - | + | + | + |
| Caffeine (20mg/dL) | - | - | - | + | + | -+- | l | - | - | + | + | + |
| Ephedrine (20mg/dL) | -- | -- | l | + | -+- | + | - | - | -- | + | + | + |
| Gentisic Acid (20mg/dL) | . I | -- | - | 十 | + | + | - | - | - | + | + | + |
| Pheny propanolamine(20mg/dL) | -- | l | - | + | + | 、十 | - | - | - | + | + | + |
| Salicylic Acid (20mg/dL) | - | - | l | + | -4- | + | l | --- | t | + | + | 十 |
| Phenothiazine (20mg/dL) | - | -- | -- | + | -+- | + | - | - | - | + | + | + |
| EDTA (80mg/dL) | - | - | l | + | + | + | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | - | ﺴﻌ | -+- | + | 十 |
| Acetylsalicylic Acid (20mg/dL) | - | - | - | 十 | + | + | --- | l | - | --- | + | + |
| Benzoylecgonine (10mg/dL) | - | - | - | + | + | + | - | l | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 十 | 十 | + |
| Cannabinol (10mg/dL) | l | l | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | + | + | + | -- | - | - | 十一 | + | + |
| Codeine (6ug/dL) | - | l | - | + | + | + | - | l | - | --- | → | 十 |
| Ethanol (1.0%) | -- | l | l | -1- | -+- | + | - | l | - | 十 | + | + |
| Methanol (10%) | - | -- | - | + | + | + | l | l | l | -+- | + | + |
| Albumin (2000mg/dL) | - | l | - | + | -+- | + | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | l | - | + | + | --- |

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| Glucose (2000mg/dL) | | | | t | + | | | + | | |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|---|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|
| Bilirubin (2mg/dL) | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | P | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | --- | ---- | | | -1- | -- | + |
| Atropine (20mg/dL) | | | 十一 | + | + | | | + | + | |
| Estriol-17-beta (1400ug/dL) | | | + | + | + | | | + | + | |
| Hemoglobin (500mg/dL) | | | --- | --- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| Pregnanediol (1500ug/dL) | | | -- | --- | --- | ----- | I | + | + | |
| Thiophene (20mg/dl) | | | + | + | + | | | + | t | |
| Ampicillin (20mg/dl) | | | l | --- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | | --- | -- | |
| Tetracycline(20mg/dl) | | | 十一 | + | + | l | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| Ketone(20mg/dl) | | | + | + | + | | | 十 | + | |

All data show that there is no interference for the listed compounds at the stated concentrations.

- e. Effect of Urine Specified Gravity and Urine pH Negative and positive urine samples containing 0 and 20 mIU/mL hCG were tested at pH values from 4 to 9 using 3 different lots by 3 different operators. Typical results are shown in the following table.

| | | 0 mlU/mL hCG | | 20mlU/mL hCG | | | | |
|----|----------|--------------|----------|--------------|----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| pH | Operator | Operator | Operator | Operator | Operator | Operator | | |
| | A | B | C | A | B | C | | |
| 4 | | | | + | + | + | | |
| 5 | | | | + | + | --- | | |
| б | | | | + | + | + | | |
| 7 | | | | + | + | + | | |
| 8 | | | | + | + | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | |
| ਰੇ | | | | + | + | - | | |

Negative and positive urine samples containing 5 and 20 mIU/mL hCG were tested at density values ranging from 1.000 to1.035 using 3 different lots by 3 different operators. Typical results are shown in the following table.

| Specific Gravity (g/mL) | 5 mlU/mL hCG | | | 20mIU/mL hCG | | |
|-------------------------|--------------|------------|------------|--------------|------------|------------|
| | Operator A | Operator B | Operator C | Operator A | Operator B | Operator C |
| 1.000 | - | - | - | + | + | + |
| 1.010 | - | - | - | + | + | + |
| 1.015 | - | - | - | + | + | + |
| 1.025 | - | - | - | + | + | + |
| 1.035 | - | - | - | + | + | + |

Data show that there is no interference from pH and specific gravity of tested urine samples.

- 2. Comparison Studies
A method comparison study was performed, comparing the results obtained from the Fastep S10 hCG Serum/Urine Combo Test to the results from predicate devices (QVUE). 100 each urine or serum samples were collected from 100 women (about half of them were pregnant, early stage at less than 5 weeks). Samples were randomly collected at various times throughout the day. Ages ranged from 20 to 49 years. The samples were

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blind labeled. Samples were tested by three different health professionals with the proposed and the predicate devices. Each person could only perform tests for one device format. For example, a person who tested the strips could not test the cassettes. Each person tested three different lots of the device and one predicate device at the same time, but not sequentially. Typical results are shown in the following tables.

#### Summary Results for Urine Strip

| New Device | Cleared device<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | |
|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | | | | | |
| | CAN AND IN - CHINES OF COLLEGION OF COLLEGION OF CA | Company come and an a cause posses | -----------<br><br>For anywood and any and any and | | |

#### Summary Results for Urine Cassette

| | Cleared device | | 10-440-4000-0000-0000-00-00-00-00-00-00-00-00-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0- | | |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| New Device .<br> | Comments of Concess of Children<br>the first and contribution of the first for the first of the first of the first of the first of the first of the first of the first of the first of the first of the first and | 10 | | | |
| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | CONSULATION CANAL I CHARACT AN AND OF CHE OF CHICAL COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION CO<br>1<br>2<br>AND AND ANNUAL COLLECT CALLERY COLLECTION COLLEGION COLLECTION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLECTION COLLECTION COLLECTIO<br> | | |

#### Summary Results for Serum Strip

| AND AND REPORTER OF IN A BREAK OR AND FORME<br>New Device<br>I<br>Complete Company consumer consumer come and can and control con can and control control control controller controller controller controller controller controller controller c | <br>Cleared device | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>C |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | |
| | And Marcel Commend Collection Collection Company Concession Complete | on A confinition for coupe of | - All American Manager Status<br>1<br>CALL AND AND AND OF A CARLES OF A FREELEMENT OF A |
| New Device | Cleared device | | |
| | PARA A PARTIC A BERTAIN A BROAD A BE A BE CONSULT A BELL A BELLERS AND | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| | I | | C +<br>ﻂ ﻟﻠﻨﺔ |

## Summary Results for Serum Cassette

The study result shows that over 95% agreements for positive samples, and 100% agreement for negative samples.

- 3. Clinical Studies
Not applicable

### 11. Conclusion

Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity and method comparison of the devices, it's concluded that Fastep S10 hCG Serum/Urine Combo Test is substantially equivalent to the predicate.

{8}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of a circular emblem containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 9, 2014

POLYMED THERAPEUTICS, INC C/O J.J XIA LSI INTERNATIONAL 12828 DOE LANE GAITHERSBURG MD 20878

Re: K132834

Trade/Device Name: Fastep S10 HCG Serum/Urine Combo Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: II Product Code: JHI Dated: November 18, 2013 Received: November 20, 2013

Dear Mr. Xia:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mr. Xia

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-frec number [phone] or [phone] or at its Internet address, http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please notes the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Parti 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/McdicalDevices/Safety/ReportaProblem/default.html for the CDRH's.Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its tolli the [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/dcfault.htm.

Sincerely yours.

CourtneyH.Lias-S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): k132834

Device Name: Fastep S10 hCG Serum/Urine Combo Test

Indications for Use:

The Fastep S10 hCG Serum/Urine Combo Test is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionic gonadotropin in human urine or serum specimens. This kit is intended for use as an aid in early detection of pregnancy. This product is only intended for prescription use in clinical laboratories and is not intended for point-of-care use settings.

Prescription Use X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

# Denise Johnson-lyles -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) k132834