Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip

K152768 · Assure Tech. Co., Ltd. · JHI · Feb 24, 2016 · Clinical Chemistry

Device Facts

• Record ID: K152768
• Device Name: Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
• Applicant: Assure Tech. Co., Ltd.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Feb 24, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Indications for Use

The Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette 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 intended for prescription use in clinical laboratories and point-of-care use settings. The Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip 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 intended for prescription use in clinical laboratories and point-of-care use settings.

Device Story

Rapid visual lateral flow immunoassay for qualitative hCG detection in urine or serum; aids early pregnancy diagnosis. Device formats include test strip or cassette housing. Input: urine or serum sample applied to absorbent pad; capillary action moves sample across membrane; mouse anti-beta hCG monoclonal antibody-dye conjugate binds hCG; captured by pre-coated goat anti-hCG polyclonal antibody on membrane. Output: colored band at test region indicates positive; absence indicates negative; colored line at control region validates test. Used in clinical laboratories and point-of-care settings; operated by healthcare professionals. Results read visually: 3 minutes for urine, 5 minutes for serum. Provides rapid confirmation of pregnancy status to inform clinical decision-making.

Clinical Evidence

Bench testing only. Method comparison study performed with 120 urine and 120 serum samples from 120 women (ages 18-49). Results showed 100% agreement with the predicate device. Analytical studies confirmed cut-off values of 10 mIU/mL (serum) and 20 mIU/mL (urine), with no interference from common exogenous compounds, glycoprotein hormones (LH, FSH, TSH), or urine matrix effects (pH 4-9, specific gravity 1.000-1.035).

Technological Characteristics

Lateral flow sandwich immunochromatographic assay. Components: absorbent pad, coated membrane, gold conjugate pad, sample pad. Detection reagent: colloidal gold. Detection limits: 10 mIU/mL (serum), 20 mIU/mL (urine). Calibration: WHO 4th International Standard. Storage: 4-30°C. Visual read-out. 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 early pregnancy detection. Intended for prescription use in clinical laboratories and point-of-care settings for women of childbearing age.

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 (K973858)

Submission Summary (Full Text)

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

A. 510(k) Number:
k152768

B. Purpose for Submission:
New device

C. Measurand:
Human Chorionic Gonadotropin (hCG)

D. Type of Test:
Qualitative chromatographic immunoassay

E. Applicant:
Assure Tech. (Hangzhou) Co., Ltd.

F. Proprietary and Established Names:
Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette
Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1155 Human chorionic gonadotropin (hCG) test system
2. Classification:
Class II
3. Product code:
JHI
4. Panel:

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Chemistry (75)

## H. Intended Use:

1. Intended use(s):

See indication for use below.

2. Indication(s) for use:

The Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette 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 intended for prescription use in clinical laboratories and point-of-care use settings.

The Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip 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 intended for prescription use in clinical laboratories and point-of-care use settings.

3. Special conditions for use statement(s):

This product is intended for prescription use in clinical laboratories and point-of-care use settings.

4. Special instrument requirements:

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

## I. Device Description:

The Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip consists of a reagent strip, which includes an absorbent pad, coated membrane, gold conjugate pad and sample pad. The Assure Tech hCG Pregnancy Serum/Urine Combo Test cassette contains the same reagent strip except that the strip is assembled in plastic device housing. The Assure Tech hCG Pregnancy Serum/Urine Combo Test (Cassette, Strip) is designed to be tested as a single cassette or dipstick device. The specimen migrates via capillary action along the membrane to react with the colored conjugate. This test measures the presence of the hCG in human urine or serum for the early detection of pregnancy. Users are able to read serum test results in 5 minutes, and read urine test results in 3 minutes.

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J. Substantial Equivalence Information:

1. Predicate device name(s):
QuickVue+ One-Step hCG Combo test from Quidel Corporation

2. Predicate 510(k) number(s):
K973858

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device: k152768 | Predicate: k973858 |
| Intended Use | Rapid qualitative detection of hCG to aid in the early detection of pregnancy. | Same |
| Sample Matrix | Urine or serum | Same |
| Test Principle | Lateral flow sandwich immuno chromatographic assay | Same |
| Detection reagent | Colloidal gold | Same |
| Read time | Serum: 5 minutes
Urine: 3 minutes | Same |
| Detection Limits | 10 mIU/mL for serum and 20 mIU/mL for urine | Same |
| Specificity | LH at 300 mIU/mL, FSH at 1000 mIU/mL, and TSH at 1000 μIU/mL | Same |
| Differences | | |
| Item | Device: k152768 | Predicate: k973858 |
| Storage | 4 – 30°C | 15 - 30°C |
| Usage | Prescription use and point of care testing | Prescription use only |
| Traceability | WHO 4^{th} International Standard | WHO 3^{rd} International Standard |
| Configuration | Strip and cassette | Cassette |
| Hook effect | hCG concentrations up to 2000 IU/mL | N/A |
| pH effect | ranges of pH 4 to 9
No effect | ranges of pH 5 to 9
No effect |
| Specific gravity effect | ranges of 1.000 to 1.035
No effect | Not provided |
| Reading Control Window | 1 window for result reading and control reading | 2 windows: Small Control Window and Large Read Result |

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| Similarities | | |
| --- | --- | --- |
| Item | Device: k152768 | Predicate: k973858 |
| | | Window |
| Read Result Window | No preprinted line on membrane | Pre-printed horizontal blue line on membrane |
| Positive result | 2 colored red/pinkish horizontal lines in control and test regions | Pink and blue plus sign in large Window, along with a blue line in small Window |
| Negative result | 1 colored line in control region only | Blue horizontal line in Large Window, along with a blue line in small Window |

## K. Standard/Guidance Document Referenced:

None

## L. Test Principle:

The Assure Tech hCG Pregnancy Serum/Urine Combo Test (Strip, Cassette) is a qualitative, lateral flow chromatographic immunoassay for the detection of human chorionic gonadotropin (hCG) in serum and urine. When the absorbent end is immersed into a sample (strip format) or a sample is applied to the absorbent end (cassette format), the sample will mix with the antibody-dye conjugate (mouse anti-beta hCG monoclonal antibody), and then flow across the pre-coated (goat anti hCG polyclonal antibody) membrane. If there is sufficient hCG in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The presence of colored line in the "C" region serves as an internal procedural control. No line in the "C" region indicates that the test is invalid.

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

### 1. Analytical performance:

#### a. Precision/Reproducibility/cut-off values:

A precision study was performed using negative human urine and serum samples spiked with hCG traceable to the WHO 4th international standard. Serum samples were tested with hCG concentrations of 0, 4, 6, 8, 10, 12, 14, 16, 20, and 50 mIU/mL. Urine samples were tested with hCG concentrations of 0, 5, 10, 12, 16, 20, 24, 30, 50 and 100 mIU/mL. The samples were measured in 10 replicates per day for 5 days using 3 different lots for each device format at three testing sites (including 2 POC sites) by 3 different operators at each site. The results are summarized in the following tables:

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Serum Strip format

| hCG Concentration (mIU/ml) | Site 1 | Site 2 | Site 3 | Total result | % Negative | %Positive |
| --- | --- | --- | --- | --- | --- | --- |
| 0 | 50-/0+ | 50-/0+ | 50-/0+ | 150-/0+ | 100 | 0 |
| 4 | 50-/0+ | 50-/0+ | 50-/0+ | 150-/0+ | 100 | 0 |
| 6 | 50-/0+ | 50-/0+ | 50-/0+ | 150-/0+ | 100 | 0 |
| 8 | 25-/25+ | 23-/27+ | 24-/26+ | 72-/78+ | 48 | 52 |
| 10 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/150+ | 0 | 100 |
| 12 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/150+ | 0 | 100 |
| 14 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/150+ | 0 | 100 |
| 16 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/150+ | 0 | 100 |
| 20 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/150+ | 0 | 100 |
| 50 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/150+ | 0 | 100 |

Serum Cassette format

| hCG Concentration (mIU/ml) | Site 1 | Site 1 | Site 1 | Total result | % Negative | %Positive |
| --- | --- | --- | --- | --- | --- | --- |
| 0 | 50-/0+ | 50-/0+ | 50-/0+ | 150-/0+ | 100 | 0 |
| 4 | 50-/0+ | 50-/0+ | 50-/0+ | 150-/0+ | 100 | 0 |
| 6 | 50-/0+ | 50-/0+ | 50-/0+ | 150-/0+ | 100 | 0 |
| 8 | 24-/26+ | 25-/25+ | 25-/25+ | 74-/76+ | 49.3 | 50.7 |
| 10 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/150+ | 0 | 100 |
| 12 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/150+ | 0 | 100 |
| 14 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/150+ | 0 | 100 |
| 16 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/150+ | 0 | 100 |
| 20 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/150+ | 0 | 100 |
| 50 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/150+ | 0 | 100 |

Urine Strip format

| hCG Concentration (mIU/ml) | Site 1 | Site 2 | Site 3 | Total result | % Negative | %Positive |
| --- | --- | --- | --- | --- | --- | --- |
| 0 | 50-/0+ | 50-/0+ | 50-/0+ | 150-/0+ | 100 | 0 |
| 5 | 50-/0+ | 50-/0+ | 50-/0+ | 150-/0+ | 100 | 0 |
| 10 | 50-/0+ | 50-/0+ | 50-/0+ | 150-/0+ | 100 | 0 |
| 12 | 50-/0+ | 50-/0+ | 50-/0+ | 150-/0+ | 100 | 0 |
| 16 | 24-/26+ | 24-/26+ | 25-/25+ | 73-/77+ | 48.7 | 51.3 |
| 20 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/150+ | 0 | 100 |
| 24 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/150+ | 0 | 100 |
| 30 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/150+ | 0 | 100 |
| 50 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/150+ | 0 | 100 |
| 100 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/150+ | 0 | 100 |

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Urine Cassette format

| hCG Concentration (mIU/ml) | Site 1 | Site 2 | Site 3 | Total result | % Negative | %Positive |
| --- | --- | --- | --- | --- | --- | --- |
| 0 | 50-/0+ | 50-/0+ | 50-/0+ | 150-/0+ | 100 | 0 |
| 5 | 50-/0+ | 50-/0+ | 50-/0+ | 150-/0+ | 100 | 0 |
| 10 | 50-/0+ | 50-/0+ | 50-/0+ | 150-/0+ | 100 | 0 |
| 12 | 50-/0+ | 50-/0+ | 50-/0+ | 150-/0+ | 100 | 0 |
| 16 | 25-/25+ | 24-/26+ | 22-/28+ | 71-/79+ | 47.3 | 52.7 |
| 20 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/150+ | 0 | 100 |
| 24 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/150+ | 0 | 100 |
| 30 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/150+ | 0 | 100 |
| 50 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/150+ | 0 | 100 |
| 100 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/150+ | 0 | 100 |

b. Linearity/assay reportable range:

Not applicable, this is a qualitative test.

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

Traceability:

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

Stability/Shelf life:

The stability testing protocol and acceptance criteria used to support the shelf life were reviewed and found acceptable. The sponsor claims that devices are stable for 24 months when stored at 39-86°F (4-30°C).

d. Detection limit:

See precision section above (M(1)(a)).

e. Analytical specificity:

An interference study was performed by adding known amounts of potential exogenous and endogenous interfering substances to both negative and positive samples (10 and 20 mIU/mL hCG for urine samples, and 5 and 10 mIU/mL for serum samples). The testing was done with three lots of the cassette format. No interference was observed from the following substances at the concentrations listed below:

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| Substance | Concentration |
| --- | --- |
| Acetaminophen | 20mg/dL |
| Acetoacetic Acid | 2000mg/dL |
| Ascorbic Acid | 20mg/dL |
| β-hydroxybutyrate | 2000mg/dL |
| Caffeine | 20mg/dL |
| Ephedrine | 20mg/dL |
| Gentisic Acid | 20mg/dL |
| Phenylpropanolamine | 20mg/dL |
| Salicylic Acid | 20mg/dL |
| Phenothiazine | 20mg/dL |
| EDTA | 80mg/dL |
| Acetylsalicylic Acid | 20mg/dL |
| Benzoylecgonine | 10mg/dL |
| Cannabinol | 10mg/dL |
| Codeine | 6ug/dL |
| Ethanol | 1.0% |
| Methanol | 10% |
| Albumin | 2000mg/dL |
| Glucose | 2000mg/dL |
| Bilirubin | 2000mg/dL |
| Atropine | 20mg/dL |
| Estriol-17-beta | 1400ug/dL |
| Hemoglobin | 2000mg/dL |
| Pregnanediol | 1500ug/dL |
| Thiophene | 20mg/dL |
| Ampicillin | 20mg/dL |
| Tetracycline | 20mg/dL |
| Ketone | 20mg/dL |
| Cholesterol | 250mg/dL |
| Triglyceride | 500mg/dL |

Hook effect:
Negative urine and serum samples were spiked with varying hCG concentrations from 62.500 IU/mL to 2000 IU/mL. The spiked samples were tested by 3 different operators using 3 different lots. The results demonstrated no hook effect at hCG concentrations up to 2000 IU/mL.

Effects of hCG β-core fragment:
Serum samples with 5mIU/mL and 10mIU/mL hCG, and urine samples with 10mIU/mL and 20mIU/mL hCG were spiked with varying concentrations of hCG β-core fragment up to 2×10⁶ pmol/L. These samples were tested by 3 different operators using 3 different lots. The results demonstrated no interference when hCG β-core fragment is ≤200 pmol/L. The sponsor has the following warning in their package insert:

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High levels of hCG β-core fragment (>200 pmol /L) can lead to false positive results for both serum and urine samples.

## Cross reactivity:

Serum samples with 5mIU/mL and 10mIU/mL hCG, and urine samples with 10mIU/mL and 20mIU/mL hCG were spiked with varying concentrations of glycoprotein hormones: Luteinizing hormone (LH), follicle-stimulating hormone (FSH), and thyroid stimulating hormone (TSH). These samples were tested by 3 different operators using 3 different lots. The results demonstrate no cross reactivity from these glycoprotein hormones up to the following concentrations:

| Glycoprotein Hormones | Concentrations |
| --- | --- |
| LH | 300 mIU/mL |
| FSH | 1000 mIU/mL |
| TSH | 1000 μIU/mL |

## Effects of urine pH:

Negative and positive urine samples containing 10 and 20 mIU/mL hCG were tested at pH values ranging from 4 to 9 using 3 different lots by 3 different operators. The results demonstrate no interference effect to the test performance from pH values of 4 to 9.

## Effects of urine Specific Gravity:

Negative and positive urine samples containing 10 and 20 mIU/mL hCG were tested with Specific Gravity values ranging from 1.007 to 1.032 using 3 different lots by 3 different operators. The results demonstrate no interference from urine Specific Gravity ranging from 1.007 to 1.032.

## f. Assay cut-off:

See precision section above (M(1)(a)).

## 2. Comparison studies:

### a. Method comparison with predicate device:

Method comparison studies were conducted at three different OB/GYN Physician's Offices. A total of 120 urine and 120 serum samples were collected from 120 donors (ages ranging from 18 to 49 years old and about half of them were pregnant at less than 5 weeks early stage). Samples were randomly collected at various times throughout the day, and tested at each site by six different healthcare professionals (three operators for strip format and three operators for cassette format) using both the proposed and the predicate devices. All samples were tested using each device format (strip and cassette). Each operator performed tests using one device format with three different lots of the candidate device and one predicate device at the same time, but not sequentially. All 3 lots of candidate devices gave the same result for each sample and the following tables summarize the representative results from one

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lot:

Serum Strip format

| Candidate device | Predicate device | + | - |
| --- | --- | --- | --- |
| | + | 60 | 0 |
| | - | 0 | 60 |

Serum Cassette format

| Candidate device | Predicate device | + | - |
| --- | --- | --- | --- |
| | + | 60 | 0 |
| | - | 0 | 60 |

Urine Strip format

| Candidate device | Predicate device | + | - |
| --- | --- | --- | --- |
| | + | 60 | 0 |
| | - | 0 | 60 |

Urine Cassette format

| Candidate device | Predicate device | + | - |
| --- | --- | --- | --- |
| | + | 60 | 0 |
| | - | 0 | 60 |

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:

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Not applicable because this is a qualitative device.

**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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