ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE)

K032661 · ACON Laboratories, Inc. · LCX · Oct 14, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032661
• Device Name: ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE)
• Applicant: ACON Laboratories, Inc.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Oct 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The ACON Quik-Check II Home Pregnancy Test Device is intended for non-professional, over-the-counter use for the qualitative identification of the elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy.

Device Story

Qualitative immunochromatographic assay; detects hCG in urine. User applies 3 drops of urine to cassette sample well; sample migrates via capillary action. hCG binds to anti-hCG-colored particle conjugate; forms colored line in test region if hCG present. Control line indicates valid test. Intended for home use by laypersons. Results interpreted visually by user. Benefits include rapid, convenient pregnancy detection.

Clinical Evidence

Consumer field study (n=113). Compared consumer performance vs. lab professional performance using subject device and predicate. Lab professionals achieved 100% concordance between subject and predicate (77 positive, 36 negative). Consumers achieved 97.4% agreement on positive samples (75/77 positive, 1 discrepant, 1 invalid) and 100% agreement on negative samples. Study confirmed ability of lay users to interpret results and follow instructions.

Technological Characteristics

Qualitative solid-phase sandwich-format immunochromatographic assay. Cassette-based form factor. Uses rabbit and goat antibodies. Sensitivity 25 mIU/mL. Standardized to WHO 3rd International Standard. No electronic components or software.

Indications for Use

Indicated for non-professional, over-the-counter use for the qualitative identification of elevated human Chorionic Gonadotropin (hCG) in urine to aid in pregnancy determination.

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 Pregnancy Test (K012215)

Submission Summary (Full Text)

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

A. 510(k) Number:
K032661

B. Analyte:
Human Chorionic Gonadotropin (HCG) Test System

C. Type of Test:
Qualitative solid-phase sandwich-format immunochromatographic assay

D. Applicant:
ACON Laboratories, Inc.

E. Proprietary and Established Names:
ACON Quik-Check II Home Pregnancy Test

F. Regulatory Information:
1. Regulation section:
CFR 862.1155
2. Classification:
Class II
3. Product Code:
LCX
4. Panel:
Clinical Chemistry (75)

G. Intended Use:
1. Indication(s) for use:
The ACON Quik-Check II Home Pregnancy Test Device is intended for non-professional, over-the-counter use for the qualitative identification of the elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy.
2. Special condition for use statement(s):
Non-professional, over-the-counter use
3. Special instrument Requirements:
N/A

H. Device Description:
The device consists of a cassette with a sample well at one end and the result and control windows in the middle. The test strip runs under the sample well and result/control windows. The user applies 3 drops of urine which migrate via capillary

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action toward the result and control windows. If hCG is present in the urine it reacts with an anti-HCG-colored particle conjugate to form a colored line in the test region of the strip. A colored line in the control region of the device indicates adequate sample volume and capillary action. Absence of a colored line in the control region is an indication of an invalid result.

I. Substantial Equivalence Information:

1. Predicate device name(s):
ACON Pregnancy Test
2. Predicate K number(s):
K012215
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Predicate | Device |
| Intended Use | OTC use for the qualitative identification of HCG to aid in detection of pregnancy | same |
| Matrix | Urine | same |
| Endpoint | Colored lines | same |
| Read Time | 3 minutes | same |
| Antibodies | Rabbit, goat | same |
| Sensitivity | 25 mIU/mL | same |
| Specificity | No interference when tested with LH, FSH, or TSH | same |
| Accuracy | >99% at cutoff | same |
| Standardization | WHO 3^{rd} International Standard | same |
| | Differences | |
| --- | --- | --- |
| Item | Predicate | Device |
| Methodology | Membrane EIA | Proprietary membrane ligand-binding EIA |
| Storage | 2-30° C | 15-30° C |

J. Standard/Guidance Document Referenced (if applicable):
None referenced

K. Test Principle:
Qualitative solid-phase sandwich-format immunochromatographic assay

L. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
N/A
b. Linearity/assay reportable range:

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N/A

c. Traceability (controls, calibrators, or method):
WHO 3rd International Standard

d. Detection limit:
25 mIU/mL

e. Analytical specificity:
Cross-reactivity was tested at 0 and 25 mIU/mL with LH (300 mIU/mL), FSH (1,000 mIU/mL), and TSH (1,000 mIU/mL) with no variation from expected results. Also tested were variations in pH (5-9), specific gravity (1.003 – 1.028) and the addition of 22 common compounds, none of which showed any variation from the expected results.

f. Assay cut-off:
See detection limit above

2. Comparison studies:

a. Method comparison with predicate device:
A consumer field study was done which included 113 participants. Urine samples were analyzed using the new device by both consumers and lab professionals and with the predicate device by lab professionals. The study evaluated the participants’ ability to understand the package insert and to accurately perform the test. When tested by lab professionals, 77 samples tested positive by both methods and 36 samples tested negative by both methods. When tested by consumers, the same samples tested negative. Of the 77 positive samples, 75 tested positive with one discrepant result and one invalid result.

b. Matrix comparison:
N/A

3. Clinical studies:

a. Clinical sensitivity:
N/A

b. Clinical specificity:
N/A

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

4. Clinical cut-off:

5. Expected values/Reference range:
Human Chorionic Gonadotropin is not found in healthy males or healthy non-pregnant females in concentrations that can be detected by the ACON QuikCheck II Home Pregnancy Test.

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**M. Conclusion:**

Based upon the information provided for the file, I recommend that the ACON QuikCheck II Home Pregnancy Test is substantially equivalent to the predicate device.