(59 days)
Not Found
Not Found
No
The device description details a standard immunoassay based on chemical reactions and colorimetric detection, with no mention of computational analysis, algorithms, or learning processes.
No.
The device is an in vitro diagnostic test for qualitative detection of human Chorionic Gonadotropin (hCG) in urine, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is an "in vitro diagnostic test kit".
No
The device description clearly outlines a physical in vitro diagnostic test kit that uses chemical reactions and a physical viewing window to detect hCG. There is no mention of software components.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "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."
This statement directly identifies the device as an in vitro diagnostic test kit.
N/A
Intended Use / Indications for Use
EZP 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.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
EZP 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. EZP Sure OneStep Pregnancy Test is based on comparative data with BeSure OneStep immuncassay, an assay for human Chorionic Gonadotropin currently being marketed.
The Principle of EZP Sure OneStep Prognancy Test is as follows:
- Both the EZP Sure OneStep Pregnancy Test and the BeSure OneStep Prograncy Test are a sandwich solid phase dyeconjugated 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 artibody immobilized in the position zone in the viewing window and produces a purple-pink color band when the hCG concertration is at or greater than 25 mlUmL. In the absence of detectable levels of hCG, there is no purple-pink band in the positive 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 EZP Sure OneStep Pregnancy Test and the BeSure OneStep Pregnancy Test are as follows:
| BeSure OneStep Pregnancy Test | EZP 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 mlU/mL |
| Urine Cup | Yes | Yes |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
OTC use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Accuracy:
A study was performed using a total 100 positive urine specimens. These specimens were assayed with EZP Sure OneStep Early Pregnancy Test and Syntron's BeSure test according to the packaging insest.
| EZ Sure OneStep Early Pregnancy Test | |||
|---|---|---|---|
| (Positive) | (Negative) | ||
| Syntron's BeSure OneStep hCG Test | (Positive) | 90 | 0 |
| (Negative) | 0 | 70 | |
| The above data do not include two specimens which were weakly reactive with both BeSure OneStap hCG and EZ Sure OneStep Early Pregnancy Tests. The reactions of these specimens were considered to be includive). 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 EZP Sure OneStep Early Prognancy Test can detect hCG in urine sample at concertration of 25 mill/mL or greater. This senativity has been determined against the World Health Organization Third International Standard. In some cases, samples containing less than 25 mlU/mL of hCG can also test as positive.
Specificity:
Menopousal Urines:
A study was conducted using urine speciment from 20 postmenspeased women. These speciments were chosen because unhe from postmenopausal women frequently interfore with prograncy tests due to cross reactivity with other gonadoropin hormones. All twenty urine specimens were negative when teeted with the EZP Sure OneStep Early Pregnancy Test.
Potentially interfering substances were added to urine samples which had hCG invels of 0 and 25 mlUmi. In each case. no interference was observed when these spiked urine samples were tested with the EZP Sure OneStep Early Prograncy Tost.
| 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 |
| 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 EZP Sure OneStep Early Pregnancy Test either:
| Homologous Hormones | Concentration in Urine | Reference |
|---|---|---|
| hTSH | 1,000 micro IU/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 mlU/mL Excel = 1.0 mlU/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 mlU/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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The EZP Sure OneStep Early Prognancy Test can detect hCG in urine sample at concertration of 25 mill/mL or greater. This senativity has been determined against the World Health Organization Third International Standard.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)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.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. 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.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.
0
Image /page/0/Picture/0 description: The image shows the word "EXCEL" in a bold, sans-serif font inside a black rounded rectangle. Below the rectangle, the phrase "Commitment to Excellence" is written in a smaller, italicized font. The word "EXCEL" is the primary visual element, emphasizing the brand or company name.
Attachment #5
13
AUG 29 1996
Summary of Safety and Effectiveness
EZQ 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. EZP Sure OneStep Pregnancy Test is based on comparative data with BeSure OneStep immuncassay, an assay for human Chorionic Gonadotropin currently being marketed.
The Principle of EZQ Sure OneStep Prognancy Test is as follows:
-
- Both the EZ9 Sure OneStep Pregnancy Test and the BeSure OneStep Prograncy Test are a sandwich solid phase dyeconjugated 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 artibody immobilized in the position zone in the viewing window and produces a purple-pink color band when the hCG concertration is at or greater than 25 mlUmL. In the absence of detectable levels of hCG, there is no purple-pink band in the positive 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 EZQ Sure OneStep Pregnancy Test and the BeSure OneStep Pregnancy Test are as follows .
- Both the EZ9 Sure OneStep Pregnancy Test and the BeSure OneStep Prograncy Test are a sandwich solid phase dyeconjugated 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 artibody immobilized in the position zone in the viewing window and produces a purple-pink color band when the hCG concertration is at or greater than 25 mlUmL. In the absence of detectable levels of hCG, there is no purple-pink band in the positive 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.
| | 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 mlU/mL |
| Urine Cup | Yes | Yes |
-
- For questions concerning the safety and effectiveness of the EZQ Sure OneStep Prognancy Test, please contact:
Min-Lee Cheng, Ph.D. 23071 E. La Palma Avenue Yorba Linda, CA 92887 Tel: (714) 692-7151
- For questions concerning the safety and effectiveness of the EZQ Sure OneStep Prognancy Test, please contact:
1
Image /page/1/Picture/0 description: The image shows the word "EXCEL" in a bold, sans-serif font, set against a black, rounded rectangle. Below the rectangle, the phrase "Commitment to Excellence" is written in a smaller font, with quotation marks around the phrase. The text is in black and the background is white.
Performance Characteristics
Curacy :
A study was performed using a total 100 positive urine specimens. These specimens were assayed with EZ? Sure OneStep Early Pregnancy Test and Syntron's BeSure test according to the packaging insest.
| 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 OneStap hCG and EZ Sure OneStep Early Pregnancy Tests. The reactions of these specimens were considered to be includive). 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 EZ9 Sure OneStep Early Prognancy Test can detect hCG in urine sample at concertration of 25 mill/mL or greater. This senativity has been determined against the World Health Organization Third International Standard. In some cases, samples containing less than 25 mlU/mL of hCG can also test as positive.
Specificity :
Menopousal Urines :
A study was conducted using urine speciment from 20 postmenspeased women. These speciments were chosen because unhe from postmenopausal women frequently interfore with prograncy tests due to cross reactivity with other gonadoropin hormones. All twenty urine specimens were negative when teeted with the EZ? Sure OneStep Early Pregnancy Test.
Potentially interfering substances were added to urine samples which had hCG invels of 0 and 25 mlUmi. In each case. no interference was observed when these spiked urine samples were tested with the EZP Sure OneStep Early Prograncy Tost.
| 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 |
2
Image /page/2/Picture/0 description: The image shows the word "EXCEL" in a bold, sans-serif font, enclosed in a rounded rectangle. Below the rectangle, the phrase "Commitment to Excellence" is written in a smaller, italicized font. The text and the rectangle are black, contrasting with what is presumably a white background.
| 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 EZP Sure OneStep Early Pregnancy Test either:
| Homologous Hormones | Concentration in Urine | Reference |
|---|---|---|
| hTSH | 1,000 $ \mu $ IU/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 mlU/mL Excel = 1.0 mlU/mL 3rd I.S.
ecision :
Intra-Assay : Within run precision was determined using 11 replicates of four specimens containing 0, 25, 100 and 450,000 mlU/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.