BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC

K071030 · Applied Dna Technologies, Inc. · JHI · Jun 29, 2007 · Clinical Chemistry

Device Facts

• Record ID: K071030
• Device Name: BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC
• Applicant: Applied Dna Technologies, Inc.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Jun 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Indications for Use

The Applied DNA Technologies Bionexia™ hCG Pregnancy Serum/Urine Cassette and Dipstick Tests are rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in serum or urine specimen to help in the early determination of pregnancy. The test kits are for health care professionals use including professionals at physician's office labs (POLs). For a final Diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.

Device Story

Rapid chromatographic immunoassay for qualitative hCG detection in serum or urine. Device consists of reagent strips in cassette or dipstick formats; membrane coated with mouse monoclonal anti-alpha-hCG antibody; dried chemical pad contains colloidal gold-conjugated mouse monoclonal anti-beta-hCG antibody; control line uses goat anti-mouse IgG. Used in physician office labs or clinical settings by healthcare professionals. Visual interpretation of test lines indicates presence of hCG. Results aid in early pregnancy determination; requires confirmatory testing for final diagnosis. Benefits include rapid, point-of-care assessment of pregnancy status.

Clinical Evidence

Bench testing only. Analytical performance evaluated via precision/reproducibility studies (n=75 per level for dipstick, n=25 for cassette) across hCG concentrations (0-100 mIU/mL). Specificity confirmed against hLH, hFSH, hTSH, and common interfering substances. Hook effect study showed no interference up to 2 million mIU/mL. Method comparison study conducted at 3 clinical sites comparing subject device to predicate using 95 serum and 94 urine samples; demonstrated 100% agreement.

Technological Characteristics

Lateral flow sandwich immunochromatographic assay. Components: reagent strip with anti-alpha hCG capture antibody-coated membrane and colloidal gold-labeled mouse anti-beta hCG monoclonal antibody. Form factors: cassette and dipstick. Storage: 2–30 °C. Qualitative visual readout. No electronic components or software.

Indications for Use

Indicated for the qualitative detection of hCG in serum or urine to aid in early pregnancy determination in patients. For use by healthcare professionals, including those in physician office labs (POLs).

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

• ACON One Step hCG Urine/Serum Test (k041946)

Submission Summary (Full Text)

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

A. 510(k) Number:
k071030

B. Purpose for Submission:
New device

C. Measurand:
Human Chorionic Gonadotropin (hCG)

D. Type of Test:
Qualitative

E. Applicant:
Applied DNA Technologies, Inc.

F. Proprietary and Established Names:
Bionexia hCG Pregnancy Serum/Urine Cassette and Dipstick Tests

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:
75-Chemistry

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H. Intended Use:

1. Intended use(s):

See indications for use below.

2. Indication(s) for use:

The Applied DNA Technologies Bionexia™ hCG Pregnancy Serum/Urine Cassette and Dipstick Tests are rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in serum or urine specimen at 20 mIU/mL and above to help in the early determination of pregnancy.

The test kits are for health care professionals use including professionals at physician’s office labs (POLs).

For a final Diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.

3. Special conditions for use statement(s):

For prescription use only.

For a final diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.

4. Special instrument requirements:

Not applicable

I. Device Description:

The Bionexia™ hCG Pregnancy Serum/Urine Cassette and Dipstick Test kit contains the test device, disposable specimen pipette and a package insert. Both test devices contain a reagent strip that contains anti-alpha hCG capture antibody coated membrane and colloidal gold particles coated with mouse anti-beta hCG monoclonal antibody.

J. Substantial Equivalence Information:

1. Predicate device name(s):

ACON One Step hCG Urine/Serum Test

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

k041946

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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 setting. | Same |
| Specimen | Urine or serum | Urine or serum |
| Principle | Lateral flow Sandwich Immunochromatographic Assay | Lateral flow Sandwich Immunochromatographic Assay |
| Positive result | 2 colored lines | 2 colored lines |
| Negative result | 1 colored line | 1 colored line |
| Detection reagent | Colloidal gold | Colloidal gold |
| Read time | Serum: 5 minutes
Urine: 3 minutes | Serum: 5 minutes
Urine: 3 minutes |
| Specificity | No effect from:
hLH: 300mIU/ml,
hFSH: 1000mIU/mL
hTSH: 1000 uIU/mL | Same |
| Storage | 2 – 30 °C | 2 – 30 °C |
| Differences | | |
| Item | Device | Predicate |
| Cutoff | 20 mIU/ml | 25 mIU/ml |

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

2000 Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s

L. Test Principle:

The Bionexia hCG Pregnancy Serum/Urine Cassette and dipstick test is a chromatographic immunoassay for the rapid qualitative determination of human chorionic gonadotropin in urine and serum specimens. The anti-Alpha hCG pre-coated membrane captures antibodies on the test band region and goat anti-mouse on the control band region. The specimen is allowed to react with anti-beta hCG monoclonal antibody. The mixture moves upward via capillary action. For a positive result, a colored band with a specific antibody- hCG-antibody-colloidal gold particle complex will form on the membrane in the test band region. The absence of a colored band in the test band region indicates a negative result.

M. Performance Characteristics (if/when applicable):

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1. Analytical performance:

a. Precision/Reproducibility:

The sponsor used five levels of male pooled urine and serum specimens spiked with hCG (WHO Fourth International Standard). Twenty-five devices from three cassette lots and one dipstick lot were tested for each hCG level tested (0, 10, 12.5, 15, 17.5, 20, 25, 30, 35, 40, and 100 mIU/mL) of serum and urine controls.

| | Dipstick | | Cassette | |
| --- | --- | --- | --- | --- |
| Level (mIU/mL) | Urine (-/+ ) n=75 | Serum (-/+ ) n=75 | Urine (-/+ ) n=25 | Serum (-/+ ) n=25 |
| 0 | 75/0 | 75/0 | 25/0 | 25/0 |
| 10 | 75/0 | 75/0 | 25/0 | 25/0 |
| 12.5 | 63/12 | 63/12 | 24/1 | 23/2 |
| 15 | 37/38 | 37/38 | 9/16 | 11/14 |
| 17.5 | 5/70 | 8/67 | 2/23 | 1/24 |
| 20 | 0/75 | 0/75 | 0/25 | 0/25 |
| 25 | 0/75 | 0/75 | 0/25 | 0/25 |
| 30 | 0/75 | 0/75 | 0/25 | 0/25 |
| 35 | 0/75 | 0/75 | 0/25 | 0/25 |
| 40 | 0/75 | 0/75 | 0/25 | 0/25 |
| 100 | 0/75 | 0/75 | 0/25 | 0/25 |

The sponsor has chosen a cutoff of 20 mIU/mL based on the above study.

b. Linearity/assay reportable range:

Not applicable

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

The test is traceable to a test that has been standardized to the WHO Fourth International Standard.

The sponsor established the shelf life and expiration date (closed unopened product) when stored refrigerated (2-8°C) or at room temperature (up to 30°C) in the sealed pouch for the duration of the shelf life. The sponsors claimed shelf life is 30 months.

d. Detection limit:

The detection limit for the ADT's Bionexia hCG Pregnancy Serum/Urine Cassette and Dipstick Test was evaluated in both the reproducibility study and a hook effect study. The sponsor determined that the cutoff is 20 mIU/mL.

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e. Analytical specificity:

Pooled negative serum and urine specimens were collected, divided into six aliquots each and were supplemented with either 300 mIU/mL luteinizing hormone (hLH), 1000 mIU/mL follicle stimulating (hFSH) or 1000 mIU/mL thyroid stimulating hormone (hTSH) at 0 and 20 mIU/mL hCG levels. Duplicates of each sample were tested using the ADT’s Bionexia hCG Pregnancy Serum/Urine Cassette and the results were read. The results demonstrated no unexpected results with the above-listed hormones in the urine or serum samples.

Prescription, OTC drugs, chemical and biological analytes were added to negative (0 mIU/mL) and positive (20 mIU/mL) spiked urine and serum pools. None of the substances tested at the concentrations listed in the package insert interfered in the assay.

Six urine specimens with varying hCG levels were altered to the following pH: normal, 3, 5, 6.5, 7.5, and 8.5 for two hCG levels (0 and 20 mIU/mL) and were tested with six devices. The samples were read and gave all negative results at 0 mIU/mL and all positive results at 20 mIU/mL of hCG.

A urine specific gravity study was conducted on negative urine samples with specific gravity ranging from 1.00 to 1.03 spiked to the following levels: 0 and 20 mIU/mL. Each sample level was tested 6 times with the ADT’s Bionexia hCG Pregnancy Serum/Urine Cassette and Dipstick Test. The sponsor’s results support the sponsor’s claim that the negative and cutoff levels are not affected by differences in specific gravity.

A hook effect study was conducted with spiked hCG serum control specimens that were tested with two cassettes for each of the following concentrations: 0, 10, 12.5, 15, 17.5, 20, 25, 30, 35, 200, 62500, 125000, 250000, 500000, 1 million and 2 million mIU/mL. The results showed that each level indicated 100% agreement in both negative and positive results and that there was no observed hook effect up to 2 million mIU/mL hCG.

f. Assay cut-off:

The cutoff for this device is 20 mIU/mL.

2. Comparison studies:

a. Method comparison with predicate device:

The ADT’s Bionexia hCG Pregnancy Serum/Urine Cassette and Dipstick Test device was evaluated at 3 clinical/professional sites by users with training typical for physician’s office labs to ascertain the products accuracy and reproducibility as compared to the predicate. Site one tested 19 positive and 27 negative serum samples. Site two tested 29 positive and 20 negative serum samples. Site one tested 18 positive and 27 negative urine samples and site two tested 29 positive and 20 negative urine samples.

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Samples were random, collected at various times throughout the day.

The combined urine and serum results from sites one and two sites are shown in the charts below.

| Serum | ACON One Step hCG Urine/Serum Test Card | | | |
| --- | --- | --- | --- | --- |
| | + | - | Total | |
| Bionexia™ | + | 48 | 0 | 48 |
| Panel | - | 0 | 47 | 47 |
| | Total | 48 | 47 | 95 |

% Agreement: 100%

| Urine | ACON One Step hCG Urine/Serum Test Card | | | |
| --- | --- | --- | --- | --- |
| | + | - | Total | |
| Bionexia™ | + | 47 | 0 | 47 |
| Panel | - | 0 | 47 | 47 |
| | Total | 47 | 47 | 94 |

% Agreement: 100%

Addition, 29 positive and 20 negative samples collected from sites 1 and 2 were also tested at a third physician's office site. The testing showed the same performance.

b. Matrix comparison:

Not applicable

3. Clinical studies:

a. Clinical Sensitivity:

See method comparison study above.

b. Clinical specificity:

See method comparison study above.

c. Other clinical supportive data (when a. and b. are not applicable):

Not applicable.

4. Clinical cut-off:

Not applicable.

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5. Expected values/Reference range:

Negative results are expected in healthy non-pregnant women and healthy men. Healthy pregnant women have hCG present in their urine and serum specimens. The amount of hCG will vary greatly with gestational age and between individuals.

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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