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.

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.

AI/ML Overview

The manufacturer performed non-clinical and clinical studies to demonstrate the substantial equivalence of the Rapidan Optima Early Pregnancy Test and the Toyo Pregnancy Test to the predicate device, "One Step HCG Urine Pregnancy Test, K043443."

Here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., "sensitivity must be >95%"). Instead, the performance is demonstrated through comparisons to a predicate device and via robust internal testing for specificity, reproducibility, and interference. The "reported device performance" is essentially that the new devices perform identically to the predicate device and show no issues in non-clinical assessments.

Acceptance Criteria (Implied)	Reported Device Performance (Rapidan Optima, 20 IU/L cut-off)	Reported Device Performance (Toyo, 25 IU/L cut-off)
Non-Clinical Performance
Cross-reactivity:	No cross-reactivity with LH (500 IU/L), FSH (1000 IU/L), TSH (1000 IU/L)	No cross-reactivity with LH (1000 IU/L), FSH (1000 IU/L), TSH (1000 IU/L)
Interfering Substances:	No variations observed with 18 common interfering substances (e.g., albumin, glucose, hemoglobin, common drugs) and varying hCG concentrations.	No variations observed with 18 common interfering substances (e.g., albumin, glucose, hemoglobin, common drugs) and varying hCG concentrations.
pH and Specific Gravity:	No significant effect on results within pH 4-9 and specific gravity 1.003-1.040. No variations observed.	No significant effect on results within pH 4-9 and specific gravity 1.003-1.040. No variations observed.
Reproducibility:	No result deviation observed in 2,000 tests across 10 hCG concentrations.	No result deviation observed in 4,000 tests across 10 hCG concentrations (for both cassette and strip types).
Clinical Performance
Agreement with Professional User:	100% agreement between lay user and professional user (50 positive, 50 negative) for Rapidan Optima Cassette.	100% agreement between lay user and professional user (50 positive, 50 negative) for Toyo Cassette. 100% agreement between lay user and professional user (50 positive, 50 negative) for Toyo Strip.
Agreement with Predicate Device (Professional User):	100% agreement with predicate device when both tested by professional users (50 positive, 50 negative) for Rapidan Optima Cassette.	100% agreement with predicate device when both tested by professional users (50 positive, 50 negative) for Toyo Cassette. 100% agreement with predicate device when both tested by professional users (50 positive, 50 negative) for Toyo Strip.
Agreement with Predicate Device (Lay vs. Professional):	100% agreement between the new device used by lay users and the predicate device used by professional users (50 positive, 50 negative) for Rapidan Optima Cassette.	100% agreement between the new device used by lay users and the predicate device used by professional users (50 positive, 50 negative) for Toyo Cassette. 100% agreement between the new device used by lay users and the predicate device used by professional users (50 positive, 50 negative) for Toyo Strip.
Ease of Use for Lay Users:	All lay users found the test easy to perform and instructions clear. Women of various backgrounds could properly use it.	All lay users found the test easy to perform and instructions clear. Women of various backgrounds could properly use it.

2. Sample Size Used for the Test Set and Data Provenance

Rapidan Optima Early Pregnancy Test (20 IU/L cut-off):

Clinical Comparison Study (for OTC use):
- Lay User vs. Professional User: 100 samples (50 positive, 50 negative).
- New Device (Professional User) vs. Predicate (Professional User): 100 samples (50 positive, 50 negative).
- New Device (Lay User) vs. Predicate (Professional User): 100 samples (50 positive, 50 negative).
Non-Clinical (Reproducibility): 2,000 individual tests (10 concentrations tested 100 times in duplicates).
Data Provenance: Not explicitly stated, but the submitter is from Turkey. The data is prospective as it involves active testing for the comparison studies.

Toyo Pregnancy Test (25 IU/L cut-off - Cassette & Strip):

Clinical Comparison Study (for OTC use - Cassette):
- Lay User vs. Professional User: 100 samples (50 positive, 50 negative).
- New Device (Professional User) vs. Predicate (Professional User): 100 samples (50 positive, 50 negative).
- New Device (Lay User) vs. Predicate (Professional User): 100 samples (50 positive, 50 negative).
Clinical Comparison Study (for OTC use - Strip):
- Lay User vs. Professional User: 100 samples (50 positive, 50 negative).
- New Device (Professional User) vs. Predicate (Professional User): 100 samples (50 positive, 50 negative).
- New Device (Lay User) vs. Predicate (Professional User): 100 samples (50 positive, 50 negative).
Clinical Comparison Study (for Hospital/Lab use - Cassette):
- New Device (Professional User) vs. Predicate (Professional User): 100 samples (50 positive, 50 negative).
Clinical Comparison Study (for Hospital/Lab use - Strip):
- New Device (Professional User) vs. Predicate (Professional User): 100 samples (50 positive, 50 negative).
Non-Clinical (Reproducibility): 4,000 individual tests (10 concentrations tested 100 times in duplicates for both cassette and strip types).
Data Provenance: Not explicitly stated, but the submitter is from Turkey. The data is prospective as it involves active testing for the comparison studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: The document refers to "professional users" in the clinical comparison studies. In each comparison of the new device to the predicate, a "professional user" performed the test, and in many cases, served as the comparative benchmark. It's implicit that these professional users' results are considered a form of ground truth or highly reliable reference. The exact number of individual professional users involved is not specified, but the data implies at least two per comparison group (one for the new device, one for the predicate, and then possibly distinct professionals for the "Lay User" comparison groups).

Qualifications of Experts: The qualifications of the "professional users" are not explicitly stated (e.g., "medical technologists with 5 years of experience"). They are simply referred to as "professional users," implying personnel with appropriate training to perform diagnostic tests.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (like 2+1 or 3+1 consensus). The ground truth for the clinical comparison studies appears to be established by the results obtained by "professional users" performing either the new device or the predicate device. For tests involving lay users, the professional user's result on the same sample is used for comparison. There is no mention of multiple experts independently reading results for discrepancy resolution.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study in the typical radiology sense (multiple readers interpreting cases with and without AI assistance to measure improvement) was not conducted.
This device is a qualitative diagnostic test (pregnancy test), not an imaging AI diagnostic tool. The "readers" are either lay users or professional users interpreting a visual line on a test strip/cassette. The studies compared the device's performance by lay users against professional users and against a predicate device. The concept of "AI assistance" or an "effect size of how much human readers improve with AI vs without AI assistance" does not apply to this type of device and study design.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in a way, the non-clinical performance data (cross-reactivity, interfering substances, pH/specific gravity, reproducibility) can be considered a standalone assessment of the device's inherent analytical capabilities, independent of human interpretation. These tests evaluate the device's chemical and biological detection accuracy under controlled conditions.

The clinical comparison studies, however, involve human-in-the-loop performance (lay users and professional users reading the results).

7. The Type of Ground Truth Used

Non-Clinical (Analytical): The ground truth for cross-reactivity, interfering substances, pH/specific gravity, and reproducibility was established by known concentrations of analytes/substances (e.g., known IU/L of hCG, known concentrations of potential interferents).
Clinical (Comparison studies): The ground truth for comparing lay users to professional users, and new devices to predicate devices, was assumed to be the results obtained by professional users using either the new device or the predicate device. This implies professional interpretation of the test results is the gold standard for these comparisons.

8. The Sample Size for the Training Set

The document describes performance studies, not the development or training of an AI algorithm. Therefore, there is no mention of a training set in the context of machine learning. The non-clinical and clinical data presented are essentially test sets for demonstrating performance and equivalence.

9. How the Ground Truth for the Training Set was Established

As there is no mention of an AI algorithm or a training set for machine learning, this question is not applicable to the provided information.

Summary

{0}------------------------------------------------

K081150

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: 2035620 CigliIzmir / Turkeywww.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 TestToyo Pregnancy Test
	Common Name	:	hCG Pregnancy Test
	Classification Name	:	Kit, test, pregnancy, hCG, over the counterKit, test, pregnancy, hCG, professional andlaboratory 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 DeviceRapidan Optima EarlyPregnancy Cassette Test	PredicateWondfo Cassette Test
Intended Use	Qualitative detection ofhCG for detection ofpregnancy	Same
Test Principle	Chromatographicimmunoassay	Same
Specimen	Urine	Same

Differences
Item	Turklab DeviceRapidan Optima EarlyPregnancy Cassette Test	PredicateWondfo Cassette Test
Cut-off point	20 IU/L	25 IU/L
Traceability	4th IS WHO	3rd IS WHO
Intended Use	For OTC	For professional andOTC

{2}------------------------------------------------

Similarities
Item	Turklab DeviceToyo Pregnancy Test /Cassette & Strip	PredicateWondfo Test /Cassette & Strip
Intended Use	Qualitative detection ofhCG for detection ofpregnancy	Same
Test Principle	Chromatographicimmunoassay	Same
Specimen	Urine	Same
Intended Use	For professional andOTC	Same
Cut-off point	25 IU/L	25 IU/L

Differences
Item	Turklab DeviceToyo Pregnancy Test /Cassette & Strip	PredicateWondfo 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 OptimaCassette Test(20 IU cut-off)		Lay User		Total
			Positive	Negative
ProfessionalUser	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 OptimaCassette 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

	Professionaluser	Predicate OTC test		Total
Lay user		Positive	Negative
Turklab'Rapidan OptimaCassette 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
ProfessionalUser	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' ToyoCassette 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

Professionaluser		Predicate Cassette OTC test		Total
Lay user		Positive	Negative
Turklab' ToyoCassette 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
ProfessionalUser	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

	Professionaluser	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

[] 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 ProfessionalCassette Test		Total
		Positive	Negative
Turklab' ToyoCassette	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 ProfessionalStrip Test		Total
		Positive	Negative
Turklab'Toyo StripProfessional 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).

{12}------------------------------------------------

Page - 2

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

{13}------------------------------------------------

Indication for Use

510(k) Number: K081150

Device Name: Rapidan Optima Early One Step hCG Urine Pregnancy Test

Indication For Use:

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

{14}------------------------------------------------

Indication for Use

510(k) Number: K081150

Device Name: Toyo One Step hCG Urine Pregnancy Test

Indication For Use:

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

Regulation Number and Section

§ 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.