FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST

K040866 · Armkel, LLC · LCX · Oct 19, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040866
• Device Name: FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST
• Applicant: Armkel, LLC
• Product Code: LCX · Clinical Chemistry
• Decision Date: Oct 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Indications for Use

The FIRST RESPONSE® One-Step Digital Pregnancy Test is an in vitro diagnostic test device that incorporates a digital read out of the test result for the early detection of pregnancy (hCG in urine) by the lay user prior to the expected menses

Device Story

Device is an at-home, OTC, battery-powered digital pregnancy test. Input: urine sample applied to absorbent tip. Principle: immunochromatographic assay using colloidal gold label; identical to analog predicate. Transformation: internal microchip with circuitry/algorithm interprets immunochemical reaction on chromatographic strip. Output: digital display screen showing 'YES+' (pregnant), '-- NO' (not pregnant), or '?' (error). Used by lay users at home. Benefit: provides clear, unambiguous digital result instead of analog lines, aiding user interpretation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological comparison and identical immunochemical assay principles to the predicate device.

Technological Characteristics

Immunochromatographic assay; plastic housing with integrated microchip and LCD screen. Detection limit: 25 mIU/mL. Standardized to WHO 3rd International Reference Standard. Single-use device. Software developed under moderate level of concern life cycle processes.

Indications for Use

Indicated for the early detection of pregnancy (hCG in urine) in women of childbearing age by lay users prior to expected menses.

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

• FIRST RESPONSE® One-Step Pregnancy Test (k992232)
• CLEARBLUE® Easy Digital Pregnancy Test (k030659)

Submission Summary (Full Text)

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

A. 510(k) Number:
k040866

B. Purpose for Submission:
New device

C. Analyte:
Human chorionic gonadotropin

D. Type of Test:
Qualitative

E. Applicant:
Armkel, LLC

F. Proprietary and Established Names:
FIRST RESPONSE® One-Step Digital Pregnancy Test

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1155 Human chorionic gonadotropin (HCG) test system
2. Classification:
II
3. Product Code:
LCX
4. Panel:
Chemistry (75)

H. Intended Use:
1. Intended use(s):
FIRST RESPONSE® One-Step Digital Pregnancy Test is an in vitro diagnostic test device that incorporates a digital read out of the test result for the early detection of pregnancy (hCG in urine) by the lay user prior to the expected menses.
2. Indication(s) for use:
FIRST RESPONSE® One-Step Digital Pregnancy Test is an in vitro diagnostic test device that incorporates a digital read out of the test result for the early detection of pregnancy (hCG in urine) by the lay user prior to the expected menses.
3. Special condition for use statement(s):
This device is intended for over-the-counter use.

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4. Special instrument Requirements:
This device is a single use device containing a micro chip and digital readout. The device was developed under adequate software life cycle processes, and the sponsor provided all the documentation necessary to support a moderate level of concern review. The documentation was reviewed and found to be sufficient for making a substantial equivalent decision.

I. Device Description:
The FIRST RESPONSE® One-Step Digital Pregnancy Test is a chromatographic strip contained within a plastic housing, which is integral with a digital component that reads and displays the result of the immunochemical reaction on the Display Screen of the device housing. The immunochemical reagents are the same as those in the predicate FIRST RESPONSE® One-Step Pregnancy Test, k992232.

J. Substantial Equivalence Information:
1. Predicate device name(s):
FIRST RESPONSE® One-Step Pregnancy Test, CLEARBLUE® Easy Digital Pregnancy Test
2. Predicate K number(s):
k992232, k030659
3. Comparison with predicate:

| Similarities | | | |
| --- | --- | --- | --- |
| Item | Device | Predicate | |
| Intended Use/Indications | Qualitative detection of hCG in urine for early detection of pregnancy | k992232 | k030659 |
| Principle | Immunochromatography | Same | Same |
| Differences | | | |
| Item | Device | Predicate | |
| Readout | Digital/LCD | Manual/visual interpretation of colored line(s) | Digital/LCD |
| Detection Limit | 25 mIU/mL | 25 mIU/mL | 50 mIU/mL |
| Standardization | WHO 3^{rd} I.S. | WHO 3^{rd} I.S. | WHO 4^{th} I.S. |

K. Standard/Guidance Document Referenced (if applicable):
WHO Third International Reference Standard

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L. Test Principle:
The test is an immunochromatographic assay.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
Not applicable
b. Linearity/assay reportable range:
Not applicable
c. Traceability (controls, calibrators, or method):
WHO Third International Reference Standard
d. Detection limit:
The analytical sensitivity of the FIRST RESPONSE® One-Step Digital Pregnancy Test is 25 mIU/mL. Five (5) replicate standards each at 50, 37.5, 25, 18.75, 12.5, and 0 mIU/mL were prepared and evaluated with the new test. All replicates of each standard at 18.75 mIU/mL and above yielded the expected results within the specified read time of three minutes. Additionally, all of the 0 mIU/mL samples produced negative results.
e. Analytical specificity:
Homologous hormones (LH, FSH, and TSH), various prescription and OTC drugs, and various urine analytes were added to aliquots of a female non-pregnant urine pool with hCG levels of 0 and 50 mIU/mL. All samples, with the exception of one 0 mIU/mL sample and one 50 mIU/mL sample spiked with hemoglobin, produced the expected results. However, additional test replicates of these samples yielded the correct expected results.
f. Assay cut-off:
See Detection limit above.

2. Comparison studies:
a. Method comparison with predicate device:
The performance of the FIRST RESPONSE® One-Step Digital Pregnancy Test was compared to that of the predicate non-digital FIRST RESPONSE® One-Step Pregnancy Test and the Clearblue® Easy Digital Pregnancy Test. In this study, 100 urine samples were collected from women who claimed not to be pregnant. These samples were tested using all three tests. All samples were negative with all tests.
In another phase of the study, 103 urine samples from pregnant women were tested using the three tests. One sample was negative with the FIRST RESPONSE® One-Step Digital Pregnancy Test and the predicate non-digital FIRST RESPONSE® One-Step Pregnancy Test but with positive with Clearblue®. One sample was negative on the subject device but positive on both predicate devices. Therefore, the subject device yielded positive results for 101 out of 103

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pregnancy urine samples when compared to Clearblue® and in 102 out of 103 when compared to the non-digital FIRST RESPONSE® One-Step Pregnancy Test.

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):
One hundred twenty-seven (127) women between the ages of 18 and 45 years, untrained in laboratory testing, participated in a consumer performance study. Each woman was given one digital test device and asked to perform the test according to the package insert instructions. The women were allowed to choose the test format (either mid-stream or dip) according to personal preference. The test result obtained by the consumer was also read and confirmed by the study monitor.

Excluding results from two defective sticks and twelve invalid results (due to too much/too little sample or digital noise), 113 valid "YES+" or "-NO" results were obtained. Of these, 4 were false positives, resulting in 96.5% correct results.

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
The expected values are based on literature.

N. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.