(419 days)
No
The device description and performance studies indicate a simple immunoassay based on chromatography, with visual interpretation of lines. There is no mention of AI, ML, image processing, or any computational analysis of the results.
No
The device is an in-vitro diagnostic test intended to detect pregnancy, not to treat or prevent a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in-vitro diagnostic test for qualitative determination of human chorionic gonadotrophin (hCG) in human urine" and that it "aid[s] in the detection of pregnancy."
No
The device description clearly outlines a physical, in-vitro diagnostic test kit that uses an immunochromatography principle with a membrane, pipette, sample well, and visible lines for interpretation. This involves hardware components and chemical reactions, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "Rapidan Optima Early One Step hCG Urine Pregnancy Test is an in-vitro diagnostic test..."
- "Toyo One Step hCG Urine Pregnancy Test is an in-vitro diagnostic test..."
This directly identifies the device as an in-vitro diagnostic.
N/A
Intended Use / Indications for Use
Rapidan Optima Early One Step hCG Urine Pregnancy Test is an in-vitro diagnostic test for qualitative determination of human chorionic gonadotrophin (hCG) in human urine. It is intended for over the counter use to detect elevated (over the cut-off value of 20 IU/L) levels of human chorionic gonadotrophin (hCG) in human urine to aid in the detection of pregnancy.
Toyo One Step hCG Urine Pregnancy Test is an in-vitro diagnostic test for qualitative determination of human chorionic gonadotrophin (hCG) in human urine. It is intended for over the counter use and for professional / laboratory use to detect elevated (over the cut-off value of 25 IU/L) levels of human chorionic gonadotrophin (hCG) in human urine to aid in the detection of pregnancy. Toyo Pregnancy Test has two formats, a cassette and a test strip format.
Product codes
LCX, JHI
Device Description
The device is a qualitative assay based on immuno chromatography principle used to detect elevated levels of hCG over the cut-off value of the device, thus showing signs of pregnancy.
Principle of the test; introduced from one end of the membrane, urine mobilizes the anti-hCG antibody complex and moves toward the other end of the membrane passing through the immobilized anti-hCG antibody test region and through the antibody recognizing control region. In the presence of hCG, the test line appears on the membrane together with the control line which confirms the antibody complex arrival to the other end of the membrane.
The assay procedure is very simple and fast (introduce sample and wait 5 minutes). The device is designed as draw sample into the pipette, and dispense it onto the sample well of the cassette or dip into sample for strip type. Sampling end is color coded. The interpretation of the result is very easy (2 lines: pregnant, 1 line: not pregnant) even for the lay person.
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
Non-professional, over the counter use and for professional and laboratory 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)
Rapidan Optima Early Pregnancy Test / 20 IU cut-off Cassette
-
Non-clinical Performance Data:
- Cross-reactivity: No cross-reactivity observed when tested 100 times each with 500 IU/L LH, 1000 IU/L FSH, and 1000 IU/L TSH.
- Interfering Substances (Recovery): Tests were done in duplicates with various chemicals added to the sample. No variations between duplicates were observed with hCG concentrations ranging from 0 to 200,000 IU/L. Tested substances include h Albumin, h Myoglobin, Ascorbic acid, Fruit acid, Cellulose, Bovine serum, Glucose, Protein, Gentisic Acid, h Haptoglobin, Cow milk, Salicylic acid, Alcohol, Peroxides, Caffeine, Hemoglobin, Atropine.
- pH and specific gravity study: Tests were done triplicates at hCG levels of 0, 10, 20, 25, 50, 80, 100 IU/L. Varying sample pH (4 to 9) and specific gravity (1.003 to 1.040) had no significant effect. No variations between triplicates were observed.
- Reproducibility: 10 different concentrations (0; 10; 20; 25; 40; 50; 10,000; 50,000; 100,000 and 200,000 IU/L) were tested 100 times each in duplicates. Total of 2,000 tests. No result deviation observed.
-
Clinical Performance Data:
- Comparison Study for OTC use (Rapidan Optima Cassette Test vs. Predicate Wondfo Cassette Test):
- Comparison between lay user and professional user for Rapidan Optima Cassette Test (20 IU cut-off): Professional User (Positive: 50, Negative: 50), Lay User (Positive: 50, Negative: 50). All results match (50 Positive, 50 Negative for both). Total N=100.
- Comparison between Turklab' Rapidan Optima Cassette Test (20 IU cut-off) and predicate test performed by professional user: Turklab (Positive: 50, Negative: 50), Predicate (Positive: 50, Negative: 50). All results match (50 Positive, 50 Negative for both). Total N=100.
- Comparison between Turklab' Rapidan Optima Cassette Test (20 IU cut-off) performed by lay user and predicate test performed by professional user: Turklab by Lay User (Positive: 50, Negative: 50), Predicate by Professional User (Positive: 50, Negative: 50). All results match (50 Positive, 50 Negative for both). Total N=100.
- Key Results: All lay users considered the test easy to perform and the labeling instructions clear and easy to follow. Women of various ages, racial backgrounds, and educational backgrounds should be able to properly use these tests.
- Comparison Study for OTC use (Rapidan Optima Cassette Test vs. Predicate Wondfo Cassette Test):
Toyo Pregnancy Test / 25 IU cut-off Cassette & Strip
-
Non-clinical Performance Data:
- Cross-reactivity: No cross-reactivity observed when tested 100 times each with 200 IU/L FH LH, 1000 IU/L FSH, and 1000 IU/L TSH.
- Interfering Substances (Recovery): Tests were done in duplicates with various chemicals added to the sample. No variations between duplicates were observed with hCG concentrations ranging from 0 to 200,000 IU/L. Tested substances include h Albumin, h Myoglobin, Ascorbic acid, Fruit acid, Cellulose, Bovine serum, Glucose, Protein, Gentisic Acid, h Haptoglobin, Cow milk, Salicylic acid, Alcohol, Peroxides, Caffeine, Hemoglobin, Atropine.
- pH and specific gravity study: Tests were done triplicates for cassette and strip type tests at hCG levels of 0, 10, 20, 25, 50, 80, 100 IU/L. Varying sample pH (4 to 9) and specific gravity (1.003 to 1.040) had no significant effect. No variations between triplicates were observed.
- Reproducibility: 10 different concentrations (0; 10; 20; 25; 40; 50; 10,000; 50,000; 100,000 and 200,000 IU/L) were tested 100 times each for cassette and strip type tests in duplicates. Total of 4,000 tests. No result deviation observed.
-
Clinical Performance Data:
- Comparison Study for OTC use (Toyo Cassette & Strip Tests vs. Predicate Wondfo Cassette & Strip Tests):
- Toyo Cassette Test:
- Comparison between lay user and professional user (25 IU cut-off): Professional User (Positive: 50, Negative: 50), Lay User (Positive: 50, Negative: 50). All results match (50 Positive, 50 Negative for both). Total N=100.
- Comparison with predicate test performed by professional user: Turklab (Positive: 50, Negative: 50), Predicate (Positive: 50, Negative: 50). All results match (50 Positive, 50 Negative for both). Total N=100.
- Comparison between lay user and predicate test performed by professional user: Turklab by Lay User (Positive: 50, Negative: 50), Predicate by Professional User (Positive: 50, Negative: 50). All results match (50 Positive, 50 Negative for both). Total N=100.
- Toyo Strip Test:
- Comparison between lay user and professional user (25 IU cut-off): Professional User (Positive: 50, Negative: 50), Lay User (Positive: 50, Negative: 50). All results match (50 Positive, 50 Negative for both). Total N=100.
- Comparison with predicate test performed by professional user: Turklab (Positive: 50, Negative: 50), Predicate (Positive: 50, Negative: 50). All results match (50 Positive, 50 Negative for both). Total N=100.
- Comparison between lay user and predicate test performed by professional user: Turklab by Lay User (Positive: 50, Negative: 50), Predicate by Professional User (Positive: 50, Negative: 50). All results match (50 Positive, 50 Negative for both). Total N=100.
- Toyo Cassette Test:
- Key Results: All lay users considered the test easy to perform and the labeling instructions clear and easy to follow. Women of various ages, racial backgrounds, and educational backgrounds should be able to properly use these tests.
- Comparison Study for OTC use (Toyo Cassette & Strip Tests vs. Predicate Wondfo Cassette & Strip Tests):
-
Comparison Study for Hospital and Laboratory use (Toyo Cassette & Strip Tests vs. Predicate hospital & laboratory use devices):
- Comparison between Turklab' Toyo Cassette Professional Test (25 IU cut-off) and predicate professional test performed by professional user: Turklab (Positive: 50, Negative: 50), Predicate (Positive: 50, Negative: 50). All results match (50 Positive, 50 Negative for both).Total N=100.
- Comparison between Turklab' Toyo Strip Professional Test (25 IU cut-off) and predicate professional test performed by professional user: Turklab (Positive: 50, Negative: 50), Predicate (Positive: 50, Negative: 50). All results match (50 Positive, 50 Negative for both). Total N=100.
- Key Results: Professional user considered the test easy to perform and the labeling instructions clear and easy to follow.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. The data is presented as comparison tables showing agreement between different users and devices.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) SUMMARY OF INFORMATION RESPECTING SAFETY AND EFFECTIVENESS Date of Summary Preparation: December 1, 2008
JUN 16 2009
| 1 | Name and Address of Submitter | ||
|---|---|---|---|
| Company name and address | : | Turklab Tibbi Malzemeler San. ve Tic. A.S. | |
| A.O.S.B. 10040 Sokak No: 20 | |||
| 35620 Cigli | |||
| Izmir / Turkey | |||
| www.turklab.com.tr | |||
| Telephone | : | 0090 232 3768081 | |
| Fax | : | 0090 232 3768040 | |
| Contact Person | : | Ms. Hilda Cil hilda@turklab.com.tr | |
| 2 | Device Name | ||
| Proprietary Name | : | Rapidan Optima Early Pregnancy Test | |
| Toyo Pregnancy Test | |||
| Common Name | : | hCG Pregnancy Test | |
| Classification Name | : | Kit, test, pregnancy, hCG, over the counter | |
| Kit, test, pregnancy, hCG, professional and | |||
| laboratory use | |||
| Product Code | : | LCX, JHI | |
| Class | : | II | |
| 21CFR § | : | 862.1155 |
3 Legally marketed Devices
One Step HCG Urine Pregnancy Test, K043443
4 Device description
The device is a qualitative assay based on immuno chromatography principle used to detect elevated levels of hCG over the cut-off value of the device, thus showing signs of pregnancy.
Principle of the test; introduced from one end of the membrane, urine mobilizes the anti-hCG antibody complex and moves toward the other end of the membrane passing through the immobilized anti-hCG antibody test region and through the antibody recognizing control region. In the presence of hCG, the test line appears on the membrane together with the control line which confirms the antibody complex arrival to the other end of the membrane.
1
The assay procedure is very simple and fast (introduce sample and wait 5 minutes). The device is designed as draw sample into the pipette, and dispense it onto the sample well of the cassette or dip into sample for strip type. Sampling end is color coded. The interpretation of the result is very easy (2 lines: pregnant, 1 line: not pregnant) even for the lay person.
5 Intended Use
Rapid immunological test device under the brands mentioned above are intended for non-professional, over the counter use and for professional and laboratory use to detect elevated levels of Human Chorionic Gonadotropin (hCG) in human urine to aid in the detection of pregnancy.
6 Comparison with Predicate Device
The Device is substantially equivalent to the "One Step HCG Urine Pregnancy Test. K043443"
Comparison charts with the above predicate device is below:
| Similarities | ||
|---|---|---|
| Item | Turklab Device | |
| Rapidan Optima Early | ||
| Pregnancy Cassette Test | Predicate | |
| Wondfo Cassette Test | ||
| Intended Use | Qualitative detection of | |
| hCG for detection of | ||
| pregnancy | Same | |
| Test Principle | Chromatographic | |
| immunoassay | Same | |
| Specimen | Urine | Same |
| Differences | ||
|---|---|---|
| Item | Turklab Device | |
| Rapidan Optima Early | ||
| Pregnancy Cassette Test | Predicate | |
| Wondfo Cassette Test | ||
| Cut-off point | 20 IU/L | 25 IU/L |
| Traceability | 4th IS WHO | 3rd IS WHO |
| Intended Use | For OTC | For professional and |
| OTC |
2
| Similarities | ||
|---|---|---|
| Item | Turklab Device | |
| Toyo Pregnancy Test / | ||
| Cassette & Strip | Predicate | |
| Wondfo Test / | ||
| Cassette & Strip | ||
| Intended Use | Qualitative detection of | |
| hCG for detection of | ||
| pregnancy | Same | |
| Test Principle | Chromatographic | |
| immunoassay | Same | |
| Specimen | Urine | Same |
| Intended Use | For professional and | |
| OTC | Same | |
| Cut-off point | 25 IU/L | 25 IU/L |
| Differences | ||
|---|---|---|
| Item | Turklab Device | |
| Toyo Pregnancy Test / | ||
| Cassette & Strip | Predicate | |
| Wondfo Test/ | ||
| Cassette & Strip | ||
| Traceability | 4th IS WHO | 3rd IS WHO |
7 - 1 Performance Data
Rapidan Optima Early Pregnancy Test / 20 IU cut-off Cassette
a- Non-clinical Performance Data (807.92/b-1) and Conclusions from Non-Clinical Tests (807.92/b-3)
No cross-reactivity was observed in any variant when tested 100 times each with below units:
| LH | 500 IU/L LH |
|---|---|
| FSH | 1000 IU/L FSH |
| TSH | 1000 IU/L TSH |
Interfering Substances (Recovery):
Tests were done in duplicates; with an addition of one of below listed chemicals to the sample in given values.
3
Test duplicates were repeated with samples containing (0; 10; 20; 25; 40; 50; 10,000; 50,000; 100,000 and 200,000 IU/L) hCG.
| h Albumin | : 10 g/L | h Haptoglobin | : 10 g/L |
|---|---|---|---|
| h Myoglobin | : 10 g/L | Cow milk | : 100 mg/L |
| Ascorbic acid | : 2 g/L | Salicylic acid | : 1 g/L |
| Fruit acid | : 4 g/L | Alcohol | : 5 ml/L |
| Cellulose | : 5 g/L | Peroxides | : 100 g/L |
| Bovine serum | : 100 g/L | Caffeine | : 20 mg/dl |
| Glucose | : 2,000 mg/dl | Hemoglobin | : 1 mg/dl |
| Protein | : 2,000 mg/dl | Atropine | : 20 mg/dl |
| Gentisic Acid | : 20 mg/dl |
No variations between duplicates were observed.
For pH and specific gravity study; tests were done triplicates at the hCG levels of 0, 10, 20, 25, 50, 80, 100 IU/L.
PH : 4 to 9 Specific gravity : 1.003 to 1.040
Varying sample pH and specific gravity within the ranges above have no significant effect on the assay results. No variations between triplicates were observed.
Reproducibility:
10 different concentrations (0; 10; 20; 25; 40; 50; 10,000; 50,000; 100,000 and 200,000 IU/L) was prepared and test devices were tested 100 times with each concentration. Tests were done in duplicates. Total of 2,000 tests were done.
No result deviation is observed in any test.
4
b- Clinical Performance Data (807.92/b-2) and Conclusions from Non-Clinical Tests (807.92/b-3)
- □ Comparison Study for OTC use: The purpose of the study was to comparison of the Turklab' OTC devices (Rapidan Optima Cassette Test) with Predicate OTC devices (Wondfo Cassette Test) performing by lay users and professional.
The results of this study are as below:
(Ref. Table A-1 at the attachment, S. 5.2.1.1 - 03. Comparison Data Sheet)
Comparison between lay user and professional user for Rapidan Optima Cassette Test (20 IU cut-off)
| Turklab' Rapidan Optima
Cassette Test
| (20 IU cut-off) | Lay User | Total | ||
|---|---|---|---|---|
| Positive | Negative | |||
| Professional | ||||
| User | Positive | 50 | 0 | 50 |
| Negative | 0 | 50 | 50 | |
| Total | 50 | 50 | 100 |
Comparison between Turklab' Rapidan Optima Cassette Test (20 IU cut-off) and predicate test performed by professional user
| Professional user | Predicate OTC test | Total | ||
|---|---|---|---|---|
| Positive | Negative | |||
| Turklab' | ||||
| Rapidan Optima | ||||
| Cassette Test | ||||
| (20 IU cut-off) | Positive | 50 | 0 | 50 |
| Negative | 0 | 50 | 50 | |
| Total | 50 | 50 | 100 |
Comparison between Turklab' Rapidan Optima Cassette Test (20 IU cut-off) performed by lay user and predicate test performed by professional user
| | Professional
user | Predicate OTC test | | Total |
|----------------------------------------------------------------|----------------------|--------------------|----------|-------|
| Lay user | | Positive | Negative | |
| Turklab'
Rapidan Optima
Cassette Test
(20 IU cut-off) | Positive | 50 | 0 | 50 |
| | Negative | 0 | 50 | 50 |
| Total | | 50 | 50 | 100 |
.
5
All lay users considered the test easy to perform and the labeling instructions clear and easy to follow. The results showed that women of various ages, racial backgrounds, and educational backgrounds should be able to properly use this tests.
Performance Data 7-2
Toyo Pregnancy Test / 25 IU cut-off Cassette & Strip
a- Non-clinical Performance Data (807.92/b-1) and Conclusions from Non-Clinical Tests (807.92/b-3)
No cross-reactivity was observed in any variant when tested 100 times each with below units:
200 INVE FH LH 1000 IU/L FSH FSH 1000 IU/L TSH TSH
Interfering Substances (Recovery):
Tests were done in duplicates; with an addition of one of below listed chemicals to the sample in given values.
Test duplicates were repeated with samples containing (0; 10; 20; 25; 40; 50; 10.000; 50,000; 100,000 and 200,000 IU/L) hCG.
| h Albumin | : 10 g/L | h Haptoglobin | : 10 g/L |
|---|---|---|---|
| h Myoglobin | : 10 g/L | Cow milk | : 100 mg/L |
| Ascorbic acid | : 2 g/L | Salicylic acid | : 1 g/L |
| Fruit acid | : 4 g/L | Alcohol | : 5 ml/L |
| Cellulose | : 5 g/L | Peroxides | : 100 g/L |
| Bovine serum | : 100 g/L | Caffeine | : 20 mg/dl |
| Glucose | : 2,000 mg/dl | Hemoglobin | : 1 mg/dl |
| Protein | : 2,000 mg/dl | Atropine | : 20 mg/dl |
| Gentisic Acid | : 20 mg/dl |
No variations between duplicates were observed.
For pH and specific gravity study; tests were done triplicates for cassette and strip type tests at the hCG levels of 0, 10, 20, 25, 50, 80, 100 IU/L.
| PH | : 4 to 9 |
|---|---|
| Specific gravity | : 1.003 to 1.040 |
Varying sample pH and specific gravity within the ranges above have no significant effect on the assay results. No variations between triplicates were observed.
6
Reproducibility:
10 different concentrations (0; 10; 20; 25; 40; 50; 10,000; 50,000; 100,000 and 200,000 IU/L) was prepared and each test devices were tested 100 times with each concentration for cassette and strip type tests. Tests were done in duplicates. Total of 4,000 tests were done.
No result deviation is observed in any test.
b- Clinical Performance Data (807.92/b-2) and Conclusions from Non-Clinical Tests (807.92/b-3)
- Comparison Study for OTC use: The purpose of the study was to comparison of the Turklab' OTC devices (Toyo Cassette & Strip Tests) with predicate OTC devices (Wondfo Cassette & Strip Tests) performing by lay users and professional.
The results of this study are as below:
Toyo Cassette Test
(Ref. Table A-2 at the attachment, S. 5.2.1.1 - 03. Comparison Data Sheet)
Comparison between lay user and professional user for Tovo Cassette Test (25 IU cut-off)
| Turklab' Toyo Cassette Test
| (25 IU cut-off) | Lay User | Total | ||
|---|---|---|---|---|
| Positive | Negative | |||
| Professional | ||||
| User | Positive | 50 | 0 | 50 |
| Negative | 0 | 50 | 50 | |
| Total | 50 | 50 | 100 |
Comparison between Turklab' Toyo Cassette Test (25 IU cut-off) and predicate test performed by professional user
| Professional user | Predicate Cassette OTC test | Total | ||
|---|---|---|---|---|
| Positive | Negative | |||
| Turklab' Toyo | ||||
| Cassette Test | ||||
| (25 IU cut-off) | Positive | 50 | 0 | 50 |
| Negative | 0 | 50 | 50 | |
| Total | 50 | 50 | 100 |
7
Comparison between Turklab' Toyo Cassette Test (25 UU cut-off) performed by
lay user and predicate test performed by professional user
| Professional
| user | Predicate Cassette OTC test | Total | ||
|---|---|---|---|---|
| Lay user | Positive | Negative | ||
| Turklab' Toyo | ||||
| Cassette Test | ||||
| (25 IU cut-off) | Positive | 50 | 0 | 50 |
| Negative | 0 | 50 | 50 | |
| Total | 50 | 50 | 100 |
Toyo Strip Test
(Ref. Table A-3 at the attachment, S. 5.2.1.1 - 03. Comparison Data Sheet)
Comparison between lay user and professional user for Toyo Strip Test (25 IU cut-off)
| Turklab' Toyo Strip Test
| (25 IU cut-off) | Lay User | Total | ||
|---|---|---|---|---|
| Positive | Negative | |||
| Professional | ||||
| User | Positive | 50 | 0 | 50 |
| Negative | 0 | 50 | 50 | |
| Total | 50 | 50 | 100 |
Comparison between Turklab' Toyo Strip Test (25 IU cut-off) and predicate test performed by professional user
| Professional user | Predicate Strip OTC test | Total | ||
|---|---|---|---|---|
| Positive | Negative | |||
| Turklab' | ||||
| Toyo Strip Test | ||||
| (25 IU cut-off) | Positive | 50 | 0 | 50 |
| Negative | 0 | 50 | 50 | |
| Total | 50 | 50 | 100 |
8
Comparison between Turklab' Toyo Strip Test (25 IU cut-off) test performed by lay user and predicate test performed by professional user
| | Professional
user | Predicate Strip OTC test | | Total |
|------------------------------------------------|----------------------|--------------------------|----------|-------|
| Lay user | | Positive | Negative | |
| Turklab'
Toyo Strip Test
(25 IU cut-off) | Positive | 50 | 0 | 50 |
| | Negative | 0 | 50 | 50 |
| Total | | 50 | 50 | 100 |
All lay users considered the test easy to perform and the labeling instructions clear and easy to follow. The results showed that women of various ages, racial backgrounds, and educational backgrounds should be able to properly use this tests.
- [] Comparison Study for Hospital and Laboratory use: The purpose of the study was to comparison of the Turklab' hospital & laboratory use devices (Toyo Cassette & Strip Tests) with predicate hospital & laboratory use devices (Wondfo Cassette & Strip Tests) performing by professional.
The results of this study are as below:
(Ref. Table B-1 at the attachment, S. 5.2.1.1 - 03. Comparison Data Sheet)
Comparison between Turklab' Toyo Cassette Professional Test (25 IU cut-off) and predicate professional test performed by professional user
| Professional user | | Predicate Professional
Cassette Test | | Total |
|--------------------------------------|----------|-----------------------------------------|----------|-------|
| | | Positive | Negative | |
| Turklab' Toyo
Cassette | Positive | 50 | 0 | 50 |
| Professional Test
(25 IU cut-off) | Negative | 0 | 50 | 50 |
| Total | | 50 | 50 | 100 |
9
(Ref. Table B-2 at the attachment, S. 5.2.1.1 - 03. Comparison Data Sheet)
Comparison between Turklab' Toyo Strip Professional Test (25 IU cut-off) and predicate professional test performed by professional user
| Professional user | | Predicate Professional
Strip Test | | Total |
|----------------------------------------------------------------|----------|--------------------------------------|----------|-------|
| | | Positive | Negative | |
| Turklab'
Toyo Strip
Professional Test
(25 IU cut-off) | Positive | 50 | 0 | 50 |
| | Negative | 0 | 50 | 50 |
| Total | | 50 | 50 | 100 |
Professional user considered the test easy to perform and the labeling instructions clear and easy to follow.
10
For Rapidan Optima and Toyo Pregnancy Tests;
c- Other information (807.92/d):
Calibration: The devices are calibrated against the positive controls for hCG. (4th IS WHO)
Quality Control: Turklab' preqnancy tests have built in Quality Control Features. After addition of the urine sample, these colored bands migrate along the membrane at the leading edge of the dye conjugate and are "removed" from the test strip completely. When the test is complete, the end user will see a red colored band in the "C" area of the test strip on negative samples and a red colored band in the "T" and "C" area on positive samples. The appearance of the control "C" band indicates that the test strip is performing properly and serves as a procedural internal control. If there are no colored bands in the "C" area and "T" area or if there is no color band in "C" area even there is a band in the "T" area; this means "invalid" test result. It is informed to user as in instruction manuals of the test devices.
- 8 Conclusion: In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this pre-market notification, Turklab Tibbi Malzemeler San. ve Tic. A.S. concludes that the new devices are safe, effective and substantially equivalent to the predicate device as described herein.
11
Image /page/11/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Turklab Medical Devices Inc. c/o Ms. Hilda Cil Deputy General Manager 10040 SK. Ataturk Organize Sanayi Bolgesi Cigli Izmir Turkey 35100
JUN 16 2009
Re: K081150
Trade/Device Names: Rapidan Optima Early One Step hCG Urine Pregnancy Test Toyo One Step hCG Urine Pregnancy Test Regulation Number: 21 CFR 862.1155
Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI, LCX Dated: May 29, 2009 Received: June 03, 2009
Dear Ms. Cil:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrb/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
A.C.H
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number: K081150
Device Name: Rapidan Optima Early One Step hCG Urine Pregnancy Test
Indication For Use:
Rapidan Optima Early One Step hCG Urine Pregnancy Test is an in-vitro diagnostic test for qualitative determination of human chorionic gonadotrophin (hCG) in human urine. It is intended for over the counter use to detect elevated (over the cut-off value of 20 IU/L) levels of human chorionic gonadotrophin (hCG) in human urine to aid in the detection of pregnancy.
Prescription Use (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K081150
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Indication for Use
510(k) Number: K081150
Device Name: Toyo One Step hCG Urine Pregnancy Test
Indication For Use:
Toyo One Step hCG Urine Pregnancy Test is an in-vitro diagnostic test for qualitative determination of human chorionic gonadotrophin (hCG) in human urine. It is intended for over the counter use and for professional / laboratory use to detect elevated (over the cut-off value of 25 IU/L) levels of human chorionic gonadotrophin (hCG) in human urine to aid in the detection of pregnancy. Toyo Pregnancy Test has two formats, a cassette and a test strip format.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use X (21 CFR Part 801 Subpart C) .
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K081150