ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001

K102760 · Atlas Medical · LCX · Aug 3, 2011 · Clinical Chemistry

Device Facts

• Record ID: K102760
• Device Name: ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001
• Applicant: Atlas Medical
• Product Code: LCX · Clinical Chemistry
• Decision Date: Aug 3, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Indications for Use

Atlas Home Pregnancy Test, Midstream (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in the urine to aid in the early detection of pregnancy.

Device Story

Device is a midstream lateral flow chromatographic immunoassay for qualitative hCG detection in urine. User immerses absorbent tip in urine stream; sample migrates via capillary action across membrane coated with mouse anti-hCG colloidal gold conjugate and polyclonal anti-hCG antiserum. Presence of hCG results in red band formation at test line; control line confirms proper flow. Used at home by lay users; results visually interpreted at 3 minutes. Provides rapid pregnancy status indication to assist clinical decision-making or personal health monitoring.

Clinical Evidence

Bench testing only. Analytical performance established via precision/reproducibility studies (n=10 replicates per concentration across 3 lots) confirming 25 mIU/mL cutoff. Specificity testing showed no cross-reactivity with LH, FSH, or TSH. Interference testing evaluated pH (4-9), specific gravity (1.000-1.035 g/mL), and various exogenous compounds. Method comparison studies (n=100 and n=51) compared lay-user midstream testing against professional testing on predicate devices, showing 100% agreement. Lay user study (n=40) confirmed ability to correctly interpret results near cutoff.

Technological Characteristics

Midstream format chromatographic immunoassay. Components: membrane with polyclonal anti-hCG antibodies, conjugate pad with colloidal gold-conjugated mouse anti-hCG antibodies, and control line with monoclonal goat anti-mouse antibodies. Detection limit: 25 mIU/ml. Visual readout. No electronic components or software.

Indications for Use

Indicated for qualitative detection of hCG in urine to aid early pregnancy detection in women of childbearing age. For over-the-counter home use.

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 Test Device (K993317)

Submission Summary (Full Text)

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

A. 510(k) Number:
k102760

B. Purpose for Submission:
New device

C. Measurand:
Human Chorionic Gonadotropin (hCG)

D. Type of Test:
Qualitative chromatographic immunoassay

E. Applicant:
Atlas Medical

F. Proprietary and Established Names:
Atlas Home Pregnancy Test (Midstream Format)

G. Regulatory Information:

| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| LCX | Class II | 21 CFR § 862.1155, Human Chorionic Gonadotropin (HCG) test system | Clinical Chemistry (75) |

H. Intended Use:

1. Intended use(s):
See indications for use below.

2. Indication(s) for use:
Atlas Home Pregnancy Test (Midstream Format) is a home use (OTC) rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in the urine to aid in the early detection of pregnancy.

3. Special conditions for use statement(s):
Atlas Home Pregnancy Test (Midstream Format) is for over-the-counter use.

4. Special instrument requirements:
None

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I. Device Description:

The Atlas Home Pregnancy Test consists of a single test strip encased in plastic device housing, with an absorbent tip. The results are generated by immersing the tip in the urine stream for a sufficient amount of time to absorb an adequate sample volume. Each test device consists of a membrane coated with polyclonal anti-hCG antiserum as a test line, mouse anti-hCG antiserum colloidal gold conjugate, and the control line which contains a monoclonal goat anti-mouse antiserum.

J. Substantial Equivalence Information:

| Predicate device name | Predicate 510(k) number |
| --- | --- |
| ACON One Step Pregnancy Test Device | k993317 |

Comparison with predicate:

| Similarities and Differences | | |
| --- | --- | --- |
| Item | Device | Predicate (k993317) |
| Indications for Use | Same | Qualitative detection of human Chorionic Gonadotropin (hCG) in urine as an aid for early detection of pregnancy. |
| User | Over-the-Counter Use | Prescription Use |
| Format | Midstream Method | Cassette |
| Test Principle | Same | Colloidal Gold Immunoassay (Membrane particle assay) |
| Detection Limit | Same | 25 mIU/mL |
| Specificity | Same | No interference when tested with FSH, LH and TSH |
| Test Time | Same | 3 minutes |
| Traceability | Same | WHO 3^{rd} International Standard |
| Storage Temperature | 36-86°F | 59-86°F |

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

None were referenced

L. Test Principle:

Atlas Home Pregnancy Test (Midstream Format) is a rapid one-step immuno-chromatographic screening test designed for the detection of human Chorionic

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Gonadotropin (hCG) in urine for early detection of pregnancy. The method employs monoclonal-dye conjugate to identify hCG in the test sample.

During testing, the urine sample reacts with the dye conjugate (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 hCG antibody on the membrane and generate a red band. Presence of the red band indicates a positive result, while its absence indicates a negative result.

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

# 1. Analytical performance:

# a. Precision/Reproducibility:

Urine specimens spiked with varying hCG concentrations (1 $^{\text{st}}$ WHO International Standard-NIBSC code 99/688) were measured in 10 replicates using three different lots. Results were visually interpreted at three minutes after sample application. Based on these results, the sponsor claimed a detection limit of $25 \, \text{mIU/mL}$ .

| hCG concentration (mIU/mL) | Lot 1 | Lot 2 | Lot 3 |
| --- | --- | --- | --- |
| 0 | 0 positive | 0 positive | 0 positive |
| | 10 negative | 10 negative | 10 negative |
| 5 | 0 positive | 0 positive | 0 positive |
| | 10 negative | 10 negative | 10 negative |
| 10 | 0 positive | 0 positive | 0 positive |
| | 10 negative | 10 negative | 10 negative |
| 15 | 1 positive | 1 positive | 0 positive |
| | 9 negative | 9 negative | 10 negative |
| 20 | 6 positive | 5 positive | 5 positive |
| | 4 negative | 5 negative | 5 negative |
| 25 | 10 positive | 10 positive | 10 positive |
| | 0 negative | 0 negative | 0 negative |
| 100 | 10 positive | 10 positive | 10 positive |
| | 0 negative | 0 negative | 0 negative |
| 250 | 10 positive | 10 positive | 10 positive |
| | 0 negative | 0 negative | 0 negative |

# b. Linearity/assay reportable range:

Linearity is not applicable since this is a qualitative test.

The test was evaluated for high dose effect. Negative urine samples were spiked with varying hCG concentrations (62,500, 125,000, 250,000, 500,000, 1,000,000 and 2,000,000 IU/mL). All tested concentrations gave a positive result.

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Additionally, the sponsor evaluated the effects of the hCG β-core fragment on the performance of the device. A urine sample [20 mIU/mL] was spiked with various concentrations of β-core-fragment hCG (0, 63,000, 125,000, 250,000, 500,000 and 1,000,000 pmol/L). Partial interference was observed at 250,000 pmol/L while higher concentrations (500,000 and 1,000,000 pmol/L) interfered with the performance of the device. The labeling includes a statement that high concentrations of β-core fragment hCG may interfere with the results.

c. Traceability, Stability, Expected values (controls, calibrators, or methods): Atlas Home Pregnancy Test (Midstream Format) is calibrated with reference material traceable to WHO 3rd International Standard.

Real-time and accelerated stability testing showed that the devices were stable and detection limit was unchanged for 24 months when stored at 36-86°F.

d. Detection limit:

Please refer to Precision Study Data in Section M1a.

e. Analytical specificity:

To evaluate cross-reactivity, negative and positive urine samples (0 and 25 mIU/mL hCG) were spiked with varying concentrations of other glycoprotein hormones such as LH, FSH and TSH. Each sample was tested in triplicate.

| Spiked Compound | Negative Urine (0 mIU/mL hCG) | Positive Urine (25 mIU/mL hCG) |
| --- | --- | --- |
| LH [300 mIU/mL] | Negative | Positive |
| FSH [1000 mIU/mL] | Negative | Positive |
| TSH [1000 mIU/mL] | Negative | Positive |

To evaluate potential interference from certain exogenous compounds, male urine samples containing 0 and 25 mIU/mL hCG were visually interpreted at three and ten minutes after sample application.

| Interferant | 3 minutes | | 10 minutes | |
| --- | --- | --- | --- | --- |
| | 0 mIU/mL hCG | 25 mIU/mL hCG | 0 mIU/mL hCG | 25 mIU/mL hCG |
| Acetaminophen [20 mg/dL] | - | + | - | + |
| Acetoacetic Acid [2000 mg/dL] | - | + | - | + |
| Ascorbic Acid [20 mg/dL] | - | + | - | + |
| B-hydroxybutyrate [2000 mg/dL] | - | + | - | + |
| Caffeine [20 mg/dL] | - | + | - | + |
| Ephedrine [20 mg/dL] | - | + | - | + |
| Gentisic Acid [20 mg/dL] | - | + | - | + |
| Phenylpropanolamine [20 mg/dL] | - | + | - | + |
| Salicyclic Acid [20 mg/dL] | - | + | - | + |
| Phenothiazine [20 mg/dL] | - | + | - | + |
| EDTA [80 mg/dL] | - | + | - | + |

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To evaluate potential interference from changes in pH, negative and positive urine samples (spiked with 0 and $25\mathrm{mIU / mL}$ hCG, respectively) were tested at pH values ranging from 4 to 9. The results were visually interpreted at three minutes after sample application.

| pH | 0 mIU/mL hCG | 25 mIU/mL hCG |
| --- | --- | --- |
| 4 | - | + |
| 5 | - | + |
| 6 | - | + |
| 7 | - | + |
| 8 | - | + |
| 9 | - | + |

To evaluate potential interference from specific gravity change, negative and positive urine samples (spiked with 5 and $25\mathrm{mIU / mL}$ hCG, respectively) were tested at specific gravity values ranging from 1.000 to $1.035\mathrm{g / mL}$ . The sponsor claimed that changes of urine specific gravity did not interfere with test results.

| Specific Gravity (g/mL) | 5 mIU/mL hCG | 25 mIU/mL hCG |
| --- | --- | --- |
| 1.000 | - | + |
| 1.010 | - | + |
| 1.015 | - | + |
| 1.025 | - | + |
| 1.035 | - | + |

# f. Assay cut-off:

The detection limit for a positive test using the Atlas Home Pregnancy Test (Midstream Format) is $25\mathrm{mIU / mL}$ .

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2. Comparison studies:

a. Method comparison with predicate device:

Two method comparison studies were performed to determine the performance characteristics of the proposed device. Samples for both studies were collected from women at early stage of pregnancy (less than 5 weeks) and women suspecting that they were pregnant. In the first study, one hundred subjects (58 pregnant and 42 non-pregnant women, aged 18 to 45 years) performed a midstream self test. Additionally, the hundred subjects collected a urine sample and it was tested on the proposed and the predicate device (ACON Midstream Pregnancy Test; k983090) by laboratory professionals. The results are presented in the table below.

| | Predicate (professional users) | |
| --- | --- | --- |
| New device (lay users) | Positive | Negative |
| Positive | 58 | 0 |
| Negative | 0 | 42 |

For the second method comparison study, fifty one subjects performed a midstream self test (two subjects had an invalid result due to insufficient sample volume) using the proposed device according to the package insert written in English and then collected a urine sample for testing by a laboratory professional. The collected urine samples were split and tested on the proposed and the predicate device (ACON One Step Pregnancy Test Device; k993317) by laboratory professionals. The results are presented in the table below.

| | Predicate (professional users) | |
| --- | --- | --- |
| New device (lay users) | Positive | Negative |
| Positive | 29 | 0 |
| Negative | 0 | 20 |

A lay user reproducibility study was also performed to evaluate whether lay users could correctly observe the test line at the claimed cutoff. Forty female lay user subjects (18 to 45 years) evaluated their own urine sample as well as a supplied spiked control urine sample near the cutoff concentration. All subjects were able to read the result of their own sample as well as the control sample near the cutoff.

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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:
This is not applicable since this is a qualitative test.

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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