← Product Code [LCX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LCX) · K033041

# ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP (K033041)

_ACON Laboratories, Inc. · LCX · Nov 21, 2003 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LCX/K033041

## Device Facts

- **Applicant:** ACON Laboratories, Inc.
- **Product Code:** [LCX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LCX.md)
- **Decision Date:** Nov 21, 2003
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1155
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Indications for Use

The ACON Quik-Check II Home Pregnancy Test Strip 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

The ACON Quik-Check II is a lateral flow immunoassay strip for home pregnancy testing. The device uses a combination of mouse monoclonal and goat polyclonal antibodies with a streptavidin-biotin ligand-binding system to detect hCG in urine. The user dips the strip into a urine sample; capillary action draws the specimen across the membrane. If hCG is present (at or above 25 mIU/mL), it binds to colored-particle-conjugated antibodies, forming a visible line in the test (T) region. A control (C) line confirms proper wicking and sample volume. The user visually interprets the presence or absence of lines to determine results. The device provides a qualitative result to aid in pregnancy determination.

## Clinical Evidence

Consumer field study (n=113) compared consumer and lab professional performance against predicate. Lab professionals showed 100% agreement (75/75 positive, 38/38 negative). Consumers showed high accuracy: 72/75 positive (1 discrepant, 2 invalid) and 36/38 negative (2 invalid). Analytical testing confirmed 25 mIU/mL sensitivity and no cross-reactivity with LH, FSH, or TSH.

## Technological Characteristics

Qualitative solid-phase sandwich-format immunochromatographic assay. Uses rabbit and goat antibodies. Standardized to WHO 3rd International Standard. Sensitivity 25 mIU/mL. Storage 15-30°C. Manual test strip form factor.

## Regulatory 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 ([K993483](/device/K993483.md))

## Submission Summary (Full Text)

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

A. 510(k) Number:
K033041

B. Analyte:
Human Chorionic Gonadotropin (HCG)

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 Strip

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

G. Intended Use:
1. Indication(s) for use:
The ACON Quik-Check II Home Pregnancy Test Strip 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 single test strip with one end designated for dipping, and control and test regions in the middle. At one end of the strip are arrows indicating

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which end of the strip is dipped into the urine and a MAX line indicating that the strip should not be dipped below this line.

# I. Substantial Equivalence Information:

1. Predicate device name(s):

ACON Pregnancy Test

2. Predicate K number(s):

K993483

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  |
|  Storage | 15-30°C | Same  |
|  Read Time | 3-10 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 3rdInternational Standard | Same  |
|   | Differences |   |
| --- | --- | --- |
|  Item | Predicate | Device  |
|  Methodology | Membrane EIA | Proprietary membrane ligand-binding EIA  |

# J. Standard/Guidance Document Referenced (if applicable):

None referenced

# K. Test Principle:

Qualitative solid-phase sandwich-format immunochromatographic assay.

The user collects a urine sample in a clean, dry container and is instructed to dip the strip into the urine for a minimum of 5 seconds, to remove the strip from the urine and place it on a non-absorbent flat service and begin timing. The urine will migrate via capillary 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. Users are instructed to read the device between 3 and 10 minutes

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

## 1. Analytical performance:

a. Precision/Reproducibility:
N/A
b. Linearity/assay reportable range:
N/A
c. Traceability (controls, calibrators, or method):
This device has been standardized to the WHO 3rd Int'l Standard
d. Detection limit:
The ACON Quik-Check II Home Pregnancy Test Strip detects urinary hCG concentrations equal to or greater than 25 mIU/mL.

HCG was spiked into known negative urines at concentrations of 10, 25, and 100 mIU/mL. The spiked samples were randomized and blinded, and tested by 35 consumers as part of a focus group study. Results were as follows:

|  Concentration (mIU/mL) | Positive results | Negative results  |
| --- | --- | --- |
|  0 | 0 | 35  |
|  10 | 4 | 31  |
|  25 | 35 | 0  |
|  100 | 35 | 0  |

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 (1,000mIU/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 caused 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, 75 samples tested positive by both methods and 38 samples tested negative by both methods. When tested by consumers, of the 38 negative samples, 36 were reported as negative with 2 invalid results. Of the 75 positive samples, 72 were

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reported as positive with one discrepant result and two invalid results.

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: N/A
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 Quik-Check II Home Pregnancy Test.

M. Conclusion:

Based upon the information provided for the file, I recommend that the ACON Quik-Check II Home Pregnancy Test Strip be found substantially equivalent to the predicate device.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LCX/K033041](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LCX/K033041)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

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