Alltest Pregnancy Rapid Combo Test Cassette

K203272 · Hangzhou AllTest Biotech Co., Ltd. · JHI · Jan 31, 2022 · Clinical Chemistry

Device Facts

• Record ID: K203272
• Device Name: Alltest Pregnancy Rapid Combo Test Cassette
• Applicant: Hangzhou AllTest Biotech Co., Ltd.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Jan 31, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Indications for Use

The Alltest Pregnancy Rapid Combo Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum to aid in the early detection of pregnancy. The test is for health care professionals use including professionals at point of care (POC).

Device Story

The Alltest Pregnancy Rapid Combo Test Cassette is a lateral flow chromatographic immunoassay used for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum samples. The device is operated by healthcare professionals in point-of-care settings. The test utilizes a sandwich immunoassay principle where the sample is absorbed into the device via capillary action and mixes with a mouse anti-beta hCG monoclonal antibody-dye conjugate. The mixture flows across a membrane precoated with goat anti-hCG polyclonal antibody. If hCG is present at or above the cut-off concentration (10 mIU/mL for serum; 20 mIU/mL for urine), a colored test line appears, indicating a positive result. The absence of a test line indicates a negative result. A control line confirms proper flow. The device provides a visual qualitative result that aids clinicians in the early detection of pregnancy.

Clinical Evidence

Method comparison study performed at three POC sites with 212 women (ages 20-49). 107 serum and 105 urine samples tested by healthcare professionals using candidate and predicate devices. Results showed 100% agreement between candidate and predicate for both matrices. Analytical performance included precision, specificity, interference, and hook effect studies using spiked samples traceable to WHO 5th IS 07/364.

Technological Characteristics

Lateral flow chromatographic immunoassay. Components: absorbent pad, coated membrane, gold conjugate pad, sample pad. Analyte: hCG. Cut-offs: 10 mIU/mL (serum), 20 mIU/mL (urine). Traceable to WHO 5th International Standard 07/364. Qualitative visual readout. No electronic components or software.

Indications for Use

Indicated for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum to aid in the early detection of pregnancy. Intended for use by healthcare professionals, including at 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

• Fastep S10 Hcg Serum/urine Combo Test (K132834)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY ONLY

## I Background Information:

A 510(k) Number

K203272

B Applicant

Hangzhou AllTest Biotech Co., Ltd

C Proprietary and Established Names

Alltest Pregnancy Rapid Combo Test Cassette

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JHI | Class II | 21 CFR 862.1155 - Human Chorionic Gonadotropin (HCG) Test System | CH - Clinical Chemistry |

## II Submission/Device Overview:

A Purpose for Submission: New device

B Measurand: Human chorionic gonadotropin (hCG)

C Type of Test: Qualitative chromatographic immunoassay

## III Intended Use/Indications for Use:

A Intended Use(s): See Indications for Use below.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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B Indication(s) for Use:
The Alltest Pregnancy Rapid Combo Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum to aid in the early detection of pregnancy.

The test is for health care professionals use including professionals at point of care (POC).

C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only

D Special Instrument Requirements:
None

IV Device/System Characteristics:

A Device Description:
The Alltest Pregnancy Rapid Combo Test Cassette measures the presence of the hormone Human Chorionic Gonadotrophin (hCG) in human urine or serum for the early detection of pregnancy. The Alltest Pregnancy Rapid Combo Test is used as a single cassette device. Each device contains a test strip that includes an absorbent pad, coated membrane, gold conjugate pad, and sample pad.

B Principle of Operation:
The Alltest Pregnancy Rapid Combo Test is a lateral flow chromatographic immunoassay. When a sample is added, 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.

V Substantial Equivalence Information:

A Predicate Device Name(s):
Fastep S10 Hcg Serum/urine Combo Test

B Predicate 510(k) Number(s):
K132834

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K203272 | K132834 |
| --- | --- | --- |
| Device Trade Name | Alltest Pregnancy Rapid Combo Test Cassette | Fastep S10 Hcg Serum/urine Combo Test |
| General Device Characteristic Similarities | | |

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| Device & Predicate Device(s): | K203272 | K132834 |
| --- | --- | --- |
| Intended Use/Indications For Use | For the qualitative detection of hCG in serum and urine to aid in the early detection of pregnancy. | Same |
| Principle | Lateral flow Sandwich Immunochromatography | Same |
| Cut-off values | 10 mIU/mL for serum and 20 mIU/mL for urine | Same |
| General Device Characteristic Differences | | |
| Read time | Serum: 5 minutes
Urine: 3 minutes | 5 minutes for both serum and urine |

VI Standards/Guidance Documents Referenced:
None referenced.

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility/Cut-Off Value:
Negative serum or urine specimens were spiked with varying hCG concentrations. The spiked samples were measured in 6 replicates each day for 5 days using 3 different lots at three testing sites representative of the intended use environment. Tests were performed by 6 different operators for each sample concentration. The cut-off values of serum and urine are 10 mIU/mL and 20 mIU/mL hCG, respectively. Results are shown in the following tables.

Serum

| hCG Concentration (mIU/mL) | Site 1 Lot 2 | | Site 2 Lot 3 | | Site 3 Lot 1 | | Total result | | % Negative | % Positive |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | - | + | - | + | - | + | - | + | | |
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 3 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 8 | 7 | 23 | 7 | 23 | 8 | 22 | 22 | 68 | 24.4 | 75.6 |
| 10 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 12 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 15 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 20 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |

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Urine

| hCG Concentration (mIU/mL) | Site 1 Lot 2 | | Site 2 Lot 3 | | Site 3 Lot 1 | | Total result | | % Negative | % Positive |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | - | + | - | + | - | + | - | + | | |
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 10 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 15 | 15 | 15 | 16 | 14 | 15 | 15 | 46 | 44 | 51.1 | 48.9 |
| 17.5 | 6 | 24 | 6 | 24 | 6 | 24 | 18 | 72 | 20 | 80 |
| 20 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 30 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 100 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |

2. Linearity:

Not applicable. This is a qualitative test.

3. Analytical Specificity/Interference:

Cross-reactivity:

The sponsor performed a study to evaluate potential cross-reactivity from LH, FSH and TSH. Negative and positive samples (10 and 20 mIU/mL hCG for urine, and 5 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 device lots of by three operators. No interference was observed for these samples for the device at LH concentrations up to 500 IU/mL, FSH concentrations up to 1000 mIU/mL, and TSH concentrations up to 1000 μIU/mL.

Interference:

The sponsor performed a study to evaluate potential interference from certain exogenous compounds, each interferent was made at 100X concentrate bulk and spiked in both hCG negative (5 mIU/mL for serum, 10 mIU/mL for urine) and hCG positive (10 mIU/mL for serum, 20 mIU/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 device lots of the testing kit. Results are shown in the following table.

The results showed that no interferences were observed from substances at the following concentrations for both negative and positive hCG urine and serum samples.

| Interferents | Concentration |
| --- | --- |
| Acetaminophen | 20 mg/dL |
| Acetoacetic Acid | 2000 mg/dL |

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| Interferents | Concentration |
| --- | --- |
| Ascorbic Acid | 20 mg/dL |
| Atropine | 20 mg/dL |
| Acetosalicylic Acid | 20 mg/dL |
| Albumin | 2000 mg/dL |
| Bilirubin (Urine) | 2 mg/dL |
| Bilirubin (Serum) | 40 mg/dL |
| Caffeine | 20 mg/dL |
| Codeine | 10 mg/dL |
| Ephedrine | 20 mg/dL |
| EDTA | 80 mg/dL |
| Ethanol | 1% |
| Gentisic Acid | 20 mg/dL |
| Glucose | 2000 mg/dL |
| Hemoglobin | 2000 mg/dL |
| Methadone | 10 mg/dL |
| Phenylpropanolamine | 20 mg/dL |
| Phenothiazine | 20 mg/dL |
| Pregnanediol | 1.5 mg/dL |
| Salicylic Acid | 20 mg/dL |
| B-hydroxybutyrate | 2000 mg/dL |
| Benzoylecgonine | 10 mg/dL |
| Cannabinol | 10 mg/dL |
| Methanol | 10% |
| Estriol-17-beta | 1.4 mg/dL |
| Thiophene | 20 mg/dL |
| Ampicillin | 20 mg/dL |
| Tetracycline | 20 mg/dL |
| Ketone | 20 mg/dL |
| Total cholesterol (Serum only) | 250 mg/dL |
| Triglycerides (Serum only) | 1200 mg/dL |
| High-density lipoprotein (Serum only) | 70 mg/dL |

**Effect of hCG beta-core fragment:**

To evaluate potential interference by hCG $\beta$-core fragment, negative and positive samples (5 and $10\mathrm{mIU/mL}$ hCG in serum; 10 and $20\mathrm{mIU/mL}$ hCG in urine) were spiked with various concentrations of hCG $\beta$-core fragment (0 to $2\times 10^{6}$ pmol/L). These samples were tested by 3 operators using 3 different lots. No false negative results were identified for the sample with $2.0\times 10^{6}$ pmol/L of hCG $\beta$-core fragment. The results indicate that high levels of hCG $\beta$-core fragment ($\geq 100$ pmol/L) can lead to a false positive results for hCG-free samples (in both serum and urine formats).

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Effect of urine pH:

To evaluate potential interference from changes in urine pH, negative and positive urine samples containing 10 and 20 mIU/mL hCG were tested with 3 lots of device by 3 operators using samples at pH 4 to 9. Data show that there is no interference from pH ranging from 4 to 9 of tested urine samples.

Effect of urine specific gravity:

To evaluate potential interference from changes in specific gravity, negative and positive urine samples containing 10 and 20 mIU/mL hCG were tested with 3 lots of device by 3 operators using samples at density values ranging from 1.001 to 1.035. Data show that there is no interference from density values ranging from 1.001 to 1.035 of tested urine samples.

Hook effect study:

To evaluate high dose hook effect, negative urine and serum samples were spiked with hCG concentrations ranging from 500 to 2,000,000 mIU/mL. The spiked samples were tested by 3 different operators using 3 device lots. The results showed no hook effect up to 2,000,000 mIU/mL.

4. Assay Reportable Range:

Not applicable. This is a qualitative test.

5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

Traceability:

The Alltest Pregnancy Rapid Combo Test Cassette is traceable to the WHO 5th International Standard (IS) for Chorionic Gonadotropin (hCG) 07/364.

6. Detection Limit:

Not applicable; see section VII. A.1. for precision near the device cutoff for urine and serum samples.

7. Assay Cut-Off:

Analytical sensitivity/cutoff study was performed using Alltest Pregnancy Rapid Combo Test Cassette. Negative serum and urine specimens were spiked with varying hCG (commercially available and traceable to the 5th WHO international Standard) concentrations. The spiked samples were randomly labeled and tested using three different lots of the device by 3 different operators. Twenty replicates were tested for each sample concentration and each device lot. The data demonstrate that the cut-off values of serum and urine are 10 mIU/mL and 20 mIU/mL hCG, respectively. Results are shown in the following tables.

Data Summary for Serum Samples

| hCG Concentration (mIU/mL) | Lot 1 | | Lot 2 | | Lot 3 | | Total result | | % Negative | % Positive |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | - | + | - | + | - | + | - | + | | |
| 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 | 0 |

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| hCG Concentration (mIU/mL) | Lot 1 | | Lot 2 | | Lot 3 | | Total result | | % Negative | % Positive |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | - | + | - | + | - | + | - | + | | |
| 3 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 | 0 |
| 5 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 | 0 |
| 8 | 5 | 15 | 3 | 17 | 5 | 15 | 13 | 47 | 22 | 78 |
| 10 | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 |
| 12 | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 |
| 15 | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 |
| 20 | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 |
| 50 | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 |

Data Summary for Urine Samples

| hCG Concentration (mIU/mL) | Lot 1 | | Lot 2 | | Lot 3 | | Total result | | % Negative | % Positive |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | - | + | - | + | - | + | - | + | | |
| 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 | 0 |
| 5 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 | 0 |
| 10 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 | 0 |
| 15 | 10 | 10 | 11 | 9 | 10 | 10 | 31 | 29 | 52 | 48 |
| 17.5 | 5 | 15 | 4 | 16 | 6 | 14 | 15 | 45 | 25 | 75 |
| 20 | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 |
| 30 | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 |
| 50 | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 |
| 100 | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 |

8. Accuracy (Instrument): Not applicable.
9. Carry-Over: Not applicable.

B Comparison Studies:

1. Method Comparison with Predicate Device:

A method comparison study was performed, comparing the results obtained from the Alltest hCG Pregnancy Rapid Combo Test Cassette to the results from predicate devices (k132834). A total of 105 urine and 107 serum samples were collected from 212 women, between the ages of 20 to 49, from three POC testing sites (about half of them were less than 5 weeks pregnant). Samples were randomly collected at various times throughout the day. All samples were randomly masked prior to analysis. Samples were tested by two different health professionals, at each site, with the candidate device (using three different lots) and the predicate device. The results are shown in the tables below.

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Summary Results for Serum

| Candidate Device | Predicate device | + | - |
| --- | --- | --- | --- |
| | + | 58 | 0 |
| | - | 0 | 49 |

Summary Results for Urine

| Candidate Device | Predicate device | + | - |
| --- | --- | --- | --- |
| | + | 53 | 0 |
| | - | 0 | 52 |

The study result shows that 100% agreement for both serum and urine samples.

2. Matrix Comparison:
Not applicable.

C Clinical Studies:

1. Clinical Sensitivity:
Not Applicable.

2. Clinical Specificity:
Not Applicable.

3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Not Applicable.

D Clinical Cut-Off:
Not Applicable.

E Expected Values/Reference Range:
Not applicable.

F Other Supportive Instrument Performance Characteristics Data:
Not Applicable.

VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

IX Conclusion:

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

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