K962580 · Excel Scientific, Inc. · LCX · Aug 29, 1996 · Clinical Chemistry
Device Facts
Record ID
K962580
Device Name
EZ SURE ONESTEP EARLY PREGNANCY TEST
Applicant
Excel Scientific, Inc.
Product Code
LCX · Clinical Chemistry
Decision Date
Aug 29, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 862.1155
Device Class
Class 2
Indications for Use
EZ¢ Sure OneStep Pregnancy Test is Excel Scientific, Inc.'s name for OTC use of solid phase migratory chromatography immunoassay in vitro diagnostic test kit for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine.
Device Story
The EZ¢ Sure OneStep Pregnancy Test is a lateral flow, solid-phase, dye-conjugated, non-enzyme immunoassay for the qualitative detection of hCG in urine. The device utilizes a gold-sol-antibody conjugate that binds to hCG in the specimen, forming an antibody-antigen complex. This complex migrates and binds to immobilized anti-hCG antibodies in a positive reaction zone, producing a visible purple-pink band when hCG concentrations are ≥ 25 mIU/mL. A control zone confirms proper reagent and device function. The test is performed by the user (OTC) by applying 4 drops of urine to the device, with results read visually after 5 minutes. The device provides a qualitative positive or negative result to assist in pregnancy determination.
Clinical Evidence
Bench testing only. Accuracy study compared 160 urine specimens (90 positive, 70 negative) against the predicate, showing 100% agreement. Analytical sensitivity confirmed at 25 mIU/mL against WHO Third International Standard. Precision studies (intra-assay and inter-assay) using 11 replicates across four concentrations (0, 25, 100, 450,000 mIU/mL) showed 100% correct identification. Specificity testing confirmed no cross-reactivity with common interfering substances (acetaminophen, caffeine, etc.) or homologous hormones (hTSH, hLH, hFSH) at specified concentrations. No interference observed in postmenopausal urine samples.
Technological Characteristics
Solid-phase migratory chromatography immunoassay (lateral flow). Gold-sol-antibody conjugate. Qualitative visual readout (purple-pink bands). Sensitivity cutoff: 25 mIU/mL. Standardized to WHO Third International Standard. Form factor includes reaction device and urine cup.
Indications for Use
Indicated for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine for the early detection of pregnancy. Intended for over-the-counter (OTC) 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
BeSure OneStep Pregnancy Test
Submission Summary (Full Text)
{0}
EXCEL
"Commitment to Excellence"
K96a580
Attachment #5
AUG 29 1996
# Summary of Safety and Effectiveness
## EZ¢ Sure OneStep Pregnancy Test
EZ¢ Sure OneStep Pregnancy Test is Excel Scientific, Inc.'s name for OTC use of solid phase migratory chromatography immunoassay in vitro diagnostic test kit for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine. EZ¢ Sure OneStep Pregnancy Test is based on comparative data with BeSure OneStep immunoassay, an assay for human Chorionic Gonadotropin currently being marketed.
The Principle of EZ¢ Sure OneStep Pregnancy Test is as follows:
1. Both the EZ¢ Sure OneStep Pregnancy Test and the BeSure OneStep Pregnancy Test are a sandwich solid phase dye-conjugated non-enzyme immunoassay. When the specimen is added to the reaction device, the gold-sol-antibody conjugate binds to the hCG molecules in the specimen forming an antibody-antigen complex. This complex binds to the anti-hCG antibody immobilized in the positive reaction zone in the viewing window and produces a purple-pink color band when the hCG concentration is at or greater than 25 mIU/mL. In the absence of detectable levels of hCG, there is no purple-pink band in the positive reaction zone. The reaction mixture continues to flow through the absorbent device, pass the positive reaction zone, producing a purple-pink color band in the control zone, demonstrating that the reagents and the device are functioning correctly.
The Differences Between the EZ¢ Sure OneStep Pregnancy Test and the BeSure OneStep Pregnancy Test are as follows:
| | BeSure OneStep Pregnancy Test | EZ¢ Sure OneStep Early Pregnancy Test |
| --- | --- | --- |
| Specimen Volume | 6 drops | 4 drops of urine |
| Incubation | 5 minutes | 5 minutes |
| Reagent | No | No |
| Step | one step | one step |
| Cutoff | 25 mIU/mL | 25 mIU/mL |
| Urine Cup | Yes | Yes |
2. For questions concerning the safety and effectiveness of the EZ¢ Sure OneStep Pregnancy Test, please contact:
Min-Lee Cheng, Ph.D.
23071 E. La Palma Avenue
Yorba Linda, CA 92887
Tel: (714) 692-7151
52-0096
{1}
EXCEL
"Commitment to Excellence"
Additional Data
Performance Characteristics
Accuracy :
A study was performed using a total 160 positive and negative urine specimens. These specimens were assayed with EZ† Sure OneStep Early Pregnancy Test and Syntron's BeSure test according to the packaging insert.
| | EZ† Sure OneStep Early Pregnancy Test | | |
| --- | --- | --- | --- |
| | | (Positive) | (Negative) |
| Syntron's BeSure | (Positive) | 90 | 0 |
| OneStep hCG Test | (Negative) | 0 | 70 |
The above data do not include two specimens which were weakly reactive with both BeSure OneStep hCG and EZ† Sure OneStep Early Pregnancy Tests. The reactions of these specimens were considered to be inclusive. The accuracy study was also performed by determining the qualitative recovery of known amounts of hCG added to the urine pool.
| Concentration of hCG in the Urine Pool (mIU/mL) | Expected | Observed |
| --- | --- | --- |
| 0 | negative | one band (negative) |
| 20 | negative | one band (negative) |
| 25 | positive | two bands (positive) |
| 100 | positive | two bands (positive) |
| 450,000 | positive | two bands (positive) |
The EZ† Sure OneStep Early Pregnancy Test can detect hCG in urine sample at concentration of 25 mIU/mL or greater. This sensitivity has been determined against the World Health Organization Third International Standard. In some cases, samples containing less than 25 mIU/mL of hCG can also test as positive.
Specificity :
Menopausal Urines :
A study was conducted using urine specimens from 20 postmenopausal women. These specimens were chosen because urine from postmenopausal women frequently interfere with pregnancy tests due to cross reactivity with other gonadotropin hormones. All twenty urine specimens were negative when tested with the EZ† Sure OneStep Early Pregnancy Test.
Potentially interfering substances were added to urine samples which had hCG levels of 0 and 25 mIU/mL. In each case, no interference was observed when these spiked urine samples were tested with the EZ† Sure OneStep Early Pregnancy Test.
| Substance | Concentration in Urine |
| --- | --- |
| Acetaminophen | 20 mg/dl |
| Acetylsalicylic Acid | 20 mg/dl |
| Ampicillin | 20 mg/dl |
| Ascorbic Acid | 20 mg/dl |
| Atropine | 20 mg/dl |
| Caffeine | 20 mg/dl |
23.03.01
{2}
EXCEL
"Commitment to Excellence"
| Gentisic Acid | 20 mg/dl |
| --- | --- |
| Glucose | 2,000 mg/dl |
| Hemoglobin | 1 mg/dl |
| Human Serum Proteins | 2,000 mg/dl |
| Tetracycline | 20 mg/dl |
| Uric Acid | 10 mg/dl |
Homologous Hormones at the concentrations indicated below were found not to interfere with the EZ↓Sure OneStep Early Pregnancy Test either:
| Homologous Hormones | Concentration in Urine | Reference |
| --- | --- | --- |
| hTSH | 1,000 μIU/mL | WHO 68/38 |
| hLH | 500 mIU/mL | WHO 2nd IRP HMG |
| hFSH | 1,000 mIU/mL | WHO 2nd IRP HMG |
## Standardization :
The reference preparation and controls have been calibrated as follows :
$$1.0 \text{ mIU/mL Excel} = 1.0 \text{ mIU/mL 3rd I.S.}$$
## Precision :
**Intra-Assay** : Within run precision was determined using 11 replicates of four specimens containing 0, 25, 100 and 450,000 mIU/mL hCG. The negative and positive values were correctly identified 100% of the time.
**Inter-Assay** : Between run precision was determined using the same four specimens of 0, 25, 100 and 450,000 mIU/mL of hCG in 11 independent assays, and with three different lots of reaction devices over a two-month period. Again, the negative and positive values were correctly identified 100% of the time.
EZ-0584
