CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY

K032159 · Access Bio Incorporate · LCX · Sep 5, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032159
• Device Name: CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY
• Applicant: Access Bio Incorporate
• Product Code: LCX · Clinical Chemistry
• Decision Date: Sep 5, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Indications for Use

The Care Start™ Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. The test is intended for over-the-counter sale to laypersons.

Device Story

Lateral flow immunochromatographic assay; detects hCG in urine. Device consists of test stick with absorbent tip, results window, and thumb grip. User places absorbent tip in urine stream or dips into collection cup. Principle: hCG in sample reacts with anti-hCG dye conjugate and immobilized anti-hCG to form visible pink line in test area; control line confirms test validity. Read time 3-10 minutes. Intended for over-the-counter home use. Provides qualitative result (positive/negative) to assist in pregnancy determination.

Clinical Evidence

Method comparison study performed with 115 samples comparing Care Start™ Pregnancy Test to predicate device. Results showed 100% concordance (46 positive, 69 negative). Analytical specificity confirmed with various common urine analytes and pH levels. Calibration performed against WHO Standard (4th IS 75/589).

Technological Characteristics

Lateral flow immunochromatographic assay; qualitative visual readout; urine specimen; non-instrumented.

Indications for Use

Indicated for laypersons for the qualitative detection of hCG in urine for early pregnancy detection.

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.

Submission Summary (Full Text)

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

A. 510(k) Number:
K032159

B. Analyte:
Human Chorionic Gonadotropin (HCG)

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

D. Applicant:
Access Bio, Inc.

E. Proprietary and Established Names:
Care Start™ Pregnancy Test and Care Start™ Plus Pregnancy Test

F. Regulatory Information:
1. Regulation section:
21CFR862.1155, Human Chorionic Gonadotropin (HCG) Test System
2. Classification:
Class II
3. Product Code:
LCX
4. Panel:
Clinical Chemistry (75)

G. Intended Use:
1. Indication(s) for use:
The Care Start™ Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. The test is intended for over-the-counter sale to laypersons.
2. Special condition for use statement(s):
Over-the-counter use only
3. Special instrument Requirements:
None

H. Device Description:
The Care Start™ Pregnancy Test consists of a test stick with an absorbent tip at one end, a results window in the middle, and a thumb grip at the other end. The absorbent strip is placed directly in the urine stream or dipped into a urine collection cup immediately after the urine is collected. The test is read at 3-10 minutes. The results window consists of a test area and a control area. The control area must always contain a visible pink line or the test is invalid. A line in the test area indicates pregnancy.

I. Substantial Equivalence Information:
1. Predicate device name(s):
Applied Biotech Sure Step hCG One-Step Pregnancy Test (prescription)

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2. Predicate K number(s):
K953988

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Methodology | Lateral flow immunoassay | Lateral flow immunoassay |
| Result format | Visible pink lines | Visible pink lines |
| Sensitivity | 20 mIU/mL | 20 mIU/mL |
| Antibodies | Mouse anti-hCG, Goat anti-mouse | Mouse anti-hCG, Goat anti-mouse |
| Differences | | |
| Item | Device | Predicate |
| Read time | 3-10 minutes | 4-10 minutes |
| Intended Use | Over the counter | Professional use |

J. Standard/Guidance Document Referenced (if applicable):
Guidance for Industry and FDA Reviewers/Staff: Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s

K. Test Principle:
If HCG is present in the urine sample it will react with an anti-HCG – dye conjugate and immobilized anti-HCG to produce a colored pink line. A control line is provided further up the strip where the excess conjugate is captured by a second immobilized anti-HCG antibody. Absence of a control line indicates a failure of the device.

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):
WHO Standard (4th IS 75/589) was used to calibrate this kit.
d. Detection limit:
20 mIU/mL
e. Analytical specificity:
Results of samples at concentrations of 0 (negative) and 20 mIU/mL (positive) were found to be unchanged by the addition of the following analytes:

| Acetaminophen | 20 mg/dL |
| --- | --- |
| Acetylsalicylic Acid | 20 mg/dL |
| Ampicillin | 20 mg/dL |
| Ascorbic Acid | 20 mg/dL |
| Atropine | 20 mg/dL |

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| Caffeine | 20 mg/dL |
| --- | --- |
| Gentisic Acid | 20 mg/dL |
| Phenothiazine | 20 mg/dL |
| Phenylpropanolamine | 20 mg/dL |
| Salicylic Acid | 20 mg/dL |
| Tetracycline | 20 mg/dL |
| Bilirubin | 2 mg/dL |
| Glucose | 2000 mg/dL |
| Hemoglobin | 1 mg/dL |
| Ketones | 20 mg/dL |
| Protein | 2000 mg/dL |
| Triglyceride | 800 mg/dL |

Additionally, adjustment of the urine pH from 3 to 10 did not change the results of any of the samples.

f. Assay cut-off: N/A

2. Comparison studies:

a. Method comparison with predicate device: 115 samples were parallel tested in a consumer study with the Care Start™ Pregnancy Test (both midstream and dip methods) and the Applied Biotech Sure Step hCG One-Step Pregnancy Test. 46 samples tested positive with both kits and 69 samples tested negative with both kits.

b. Matrix comparison: Both the predicate and the device are used with a urine matrix

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): N/A

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 Care Start™ Pregnancy Test

M. Conclusion: I recommend that the Care Start™ Pregnancy Test is substantially equivalent to the predicate device.