The Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionin in human urine or serum specimens. This kit is intended for use as an aid in early detection of pregnancy.

This product is intended for prescription use in clinical laboratories and point-of-care use settings.

The Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionic gonadotropin in human urine or serum specimens. This kit is intended for use as an aid in early detection of pregnancy.

This product is intended for prescription use in clinical laboratories and point-of-care use settings.

Device Description

Assure Tech hCG Pregnancy Serum/Urine Combo Test (Cassette, Strip) measures the presence of the hormone Human Chorionic Gonadotrophin (hCG) in human urine or serum for the early detection of pregnancy. During pregnancy, hCG is produced by the placenta shortly after the embryo attaches to the uterine lining. The test devices are in two different formats: Strip, Cassette.

AI/ML Overview

Here's an analysis of the acceptance criteria and study details for the Assure Tech hCG Pregnancy Serum/Urine Combo Test, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to its "precision/reproducibility/cut-off value" and "method comparison" studies. The goal is to perform accurately around the established cut-off values and show strong agreement with a predicate device.

Acceptance Criteria (Inferred from Study Outcomes)	Reported Device Performance
Precision/Reproducibility: Establish accurate detection at and around cut-off values.	Serum Cut-off (10 mIU/mL):
	- At 8 mIU/mL (below cut-off), device showed ~48-49% positive results (some false positives, but expected given proximity to cut-off).
	- At 10 mIU/mL (cut-off), device showed 100% positive results.
	- At 0, 4, 6 mIU/mL (negative controls), device showed 100% negative results.
	Urine Cut-off (20 mIU/mL):
	- At 16 mIU/mL (below cut-off), device showed ~51-53% positive results (some false positives, but expected given proximity to cut-off).
	- At 20 mIU/mL (cut-off), device showed 100% positive results.
	- At 0, 5, 10, 12 mIU/mL (negative controls), device showed 100% negative results.
Method Comparison: Demonstrate substantial equivalence to a legally marketed predicate device.	100% agreement between the Assure Tech hCG Pregnancy Serum/Urine Combo Test (Cassette/Strip) and the predicate device (QuickVue+) for:
	- Urine Strip: 60 positive, 60 negative samples (100% agreement with predicate).
	- Urine Cassette: 60 positive, 60 negative samples (100% agreement with predicate).
	- Serum Strip: 60 positive, 60 negative samples (100% agreement with predicate).
	- Serum Cassette: 60 positive, 60 negative samples (100% agreement with predicate).
Stability: Maintain performance over time.	Stable at 4-30°C for 24 months (based on accelerated stability at 50°C and real time stability at 4°C and 30°C).
Specificity/Cross-Reactivity: No significant interference from related hormones.	No interference observed for LH, FSH, and TSH at tested concentrations (up to 300 IU/mL LH, 1000 mIU/mL FSH, 1000 µIU/mL TSH). False positive was observed above 200 pmol/L ß-core fragment hCG. No hook effect observed up to 2,000,000 mIU/mL hCG.
Interference: No significant interference from common exogenous or endogenous substances.	No interference observed for a wide range of compounds (e.g., Acetaminophen, Acetoacetic Acid, Ascorbic Acid, Bilirubin, Caffeine, Ethanol, Glucose, Hemoglobin, Lipoprotein, etc.) at stated concentrations and within specified read times. No interference from urine pH (4-9) or specific gravity (1.000-1.035).

Study Details

Sample Size and Data Provenance:
- Test Set (Precision/Reproducibility): For each format (Serum Strip, Serum Cassette, Urine Strip, Urine Cassette), 150 replicates were used for each hCG concentration level (10 replicates per site x 3 sites x 5 days for each of 3 lots = 450 total data points per concentration level for each format). Total tests: 10 concentrations per serum format, 10 for urine strip, 10 for urine cassette. This would be a massive number, but the table combines the three lots and three operators. So for each concentration, 150 total tests (3 sites x 50 tests per site). This means for Serum Strip, 150 tests at 0 mIU/mL, 150 tests at 4 mIU/mL, and so on.
  - Provenance: This data was generated in vitro by spiking negative serum/urine specimens with hCG. The origin of the negative serum/urine is not specified (e.g., country) but is likely lab-obtained.
- Test Set (Method Comparison): 120 urine samples and 120 serum samples were collected.
  - Provenance: The samples were collected prospectively from 120 women (ages 18-49, about half pregnant and in early stages < 5 weeks) from three testing sites. The country of origin is not explicitly stated, but the submitter is in Hangzhou, China, and the regulatory consultant is in Maryland, USA. It's common for such studies to be multi-site, and given the FDA submission, the data would ideally meet international standards.
- Training Set: The document does not describe a training set as this is an immunoassay, not a machine learning algorithm.
Number of Experts and Qualifications (Test Set Ground Truth):
- For the precision study, results were interpreted by "three different operators." Their qualifications are not specified beyond being "operators."
- For the method comparison study, samples were tested by "six different health professionals." Their specific qualifications (e.g., type of professional, experience level) are not detailed.
- The primary "ground truth" for these studies is the known concentration of spiked hCG for precision, and the result from the predicate device for method comparison.
Adjudication Method (Test Set):
- The document does not explicitly describe an adjudication method for conflicting results if they occurred during the precision or method comparison studies. For the precision study, it shows the aggregate positive/negative counts. For the method comparison, it reports 100% agreement, suggesting no need for adjudication for the final results presented.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study in the typical sense (where human readers interpret cases with and without AI assistance to measure improvement) was not done. This device is a diagnostic test kit (immunoassay), not an AI algorithm assisting human interpretation of complex data (like radiology images). The "comparison studies" section refers to comparing the new device's results to a predicate device, and the "operators" or "health professionals" are performing the test and reading the visual result, not interpreting complex cases.
Standalone Performance:
- Yes, the performance presented for the "Analytical Performance" (precision, stability, specificity, interference) and "Comparison Studies" represents the standalone performance of the Assure Tech hCG Pregnancy Serum/Urine Combo Test. It is an algorithm-only (test kit only) without a human-in-the-loop interaction beyond performing the test and visually reading the results.
Type of Ground Truth Used:
- Precision/Reproducibility: The ground truth was based on known spiked concentrations of hCG (traceable to the 4th WHO international Standard).
- Method Comparison: The ground truth was established by comparison to a legally marketed predicate device (QuickVue+ One-Step hCG Combo test, K973858), implying the predicate device's results serve as the reference. Additionally, the samples were collected from "pregnant" and "non-pregnant" women, suggesting clinical status (outcomes data regarding pregnancy) was also a factor in sample selection.
Sample Size for the Training Set:
- Not applicable. This is an immunoassay kit, not a machine learning model, so there is no "training set."
How Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 24, 2016

ASSURE TECH., INC. C/O JOE SHIA REGULATORY CONSULTANT 504 EAST DIAMOND AVE. SUITE I GAITHERSBURG MD 20877

Re: K152768

Trade/Device Name: Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: February 12, 2016 Received: February 22, 2016

Dear Joe Shia:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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

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medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney H. Lias -S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152768

Device Name

Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip

Indications for Use (Describe)

This product is intended for prescription use in clinical laboratories and point-of-care use settings.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CER 801 Subpart D)	Over-The-Counter Use (21 CER 801 Subpart C)
----------------------------------------------	---------------------------------------------

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510(k) SUMMARY

1. Date:	February 23, 2016
2. Submitter:	Assure Tech. (Hangzhou) Co., Ltd.2nd. Floor, Building 1, No.10, Xiyuansan RoadHangzhou, China, 310030
3. Contact person:	Joe ShiaLSI International Inc.504 East Diamond Ave., Suite IGaithersburg, MD 20877Telephone: 240-505-7880Fax: 301-916-6213Email:shiajl@yahoo.com
4. Device Name:	Assure Tech hCG Pregnancy Serum/Urine Combo TestCassetteAssure Tech hCG Pregnancy Serum/Urine Combo TestStrip

Classification: Class II

ProductCode	CFR #	Panel
JHI	862.1155, Human chorionicgonadotropin (HCG) test system	Clinical Chemistry

1. Predicate Devices:
  K973858, QuickVue+ One-Step hCG Combo test, Quidel Corporation
1. Intended Use
  The Assure Tech hCG Pregnancy Serum/Urine Combo Test (Cassette, Strip) is a rapid chromatographic immunoassay for the visual, qualitative detection of human chorionic gonadotropin in human urine or serum specimens to aid in early detection of pregnancy. This device is intended for prescription use in clinical laboratories and point-of-care use settings.
1. Device Description
  Assure Tech hCG Pregnancy Serum/Urine Combo Test (Cassette, Strip) measures the presence of the hormone Human Chorionic Gonadotrophin (hCG) in human urine or serum for the early detection of pregnancy. During pregnancy, hCG is produced by the placenta shortly after the embryo attaches to the uterine lining. The test devices are in two different formats: Strip, Cassette.
1. Substantial Equivalence Information
  A summary comparison of features of the Assure Tech hCG Pregnancy Serum/Urine Combo Test (Cassette, Strip) and the predicate device is provided in the following table.

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Item	Device	Predicate
Intended Use	Rapid qualitative detection ofhCG to aid in the early detectionof pregnancy.	Same
Specimen	Urine or serum	Same
Principle	Lateral flow SandwichImmunochromatographic Assay	Same
Detection reagent	Colloidal gold	Same
Read time	Serum: 5 minutesUrine: 3 minutes	Same
Usage	For prescription use	Same
Cut-Off Values	10 mIU/mL for serum and20 mIU/mL for urine	Same
Configurations	Strip and cassette	Same
Storage	4 – 30°C	Same
Reading Control Window	1 window for result reading andcontrol reading	2 windows: Small Control Window and Large Read Result Window
Read Result Window	No preprinted line on membrane	Pre-printed horizontal blue line on membrane
Positive result	2 colored red/pinkish horizontallines in control and test regions	Pink and blue plus signin large Window, alongwith a blue line in smallWindow
Negative result	1 colored line in control regiononly	Blue horizontal line inLarge Window, alongwith a blue line in smallWindow

9. Test Principle

It is a lateral flow chromatographic immunoassay. When the absorbent end is immersed into a sample, the sample is absorbed into the device by capillary action and mixes with the antibody-dye conjugate (mouse anti-beta hCG monoclonal antibody), flowing across the pre-coated (Goat anti hCG polyclonal antibody) membrane. At analyte concentration above the target cut off, it produces a colored test line that indicates a positive result. When analyte concentration is below the cutoff, no colored band shows in the test region, indicating a negative result. No line in the "C" region indicates that the test is invalid.

1. Performance Characteristics

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Analytical Performance

a. Precision/Reproducibility/Cut-Off Value

Negative serum or urine specimens were spiked with varying hCG (commercially available and traceable to the 4th WHO international Standard) concentrations. The spiked samples were measured in 10 replicates using 3 different lots for each format at three testing sites. Tests were performed by three different operators for each sample concentration at each site for 5 days. Results are shown in the following tables.

hCGConcentration(mIU/mL)	-	Site 1	+	-	Site 2	+	-	Site 3	+	-
0	50	0	50	0	50	0	150	0	100%	0
4	50	0	50	0	50	0	150	0	100%	0
6	50	0	50	0	50	0	150	0	100%	0
8	25	25	23	27	24	26	72	78	48%	52%
10	0	50	0	50	0	50	0	150	0	100%
12	0	50	0	50	0	50	0	150	0	100%
14	0	50	0	50	0	50	0	150	0	100%
16	0	50	0	50	0	50	0	150	0	100%
20	0	50	0	50	0	50	0	150	0	100%
50	0	50	0	50	0	50	0	150	0	100%

Serum Strip format

Serum Cassette format

hCGConcentration(mIU/mL)	Site 1		Site 2		Site 3		Total result		%Negative	%Positive
	-	+	-	+	-	+	-	+
0	50	0	50	0	50	0	150	0	100%	0
4	50	0	50	0	50	0	150	0	100%	0
6	50	0	50	0	50	0	150	0	100%	0
8	24	26	25	25	25	25	74	76	49.3%	50.7%
10	0	50	0	50	0	50	0	150	0	100%
12	0	50	0	50	0	50	0	150	0	100%
14	0	50	0	50	0	50	0	150	0	100%
16	0	50	0	50	0	50	0	150	0	100%
20	0	50	0	50	0	50	0	150	0	100%
50	0	50	0	50	0	50	0	150	0	100%

Urine Strip format

hCGConcentration(mIU/mL)	Site 1		Site 2		Site 3		Total result		%Negative	%Positive
	-	+	-	+	-	+	-	+
0	50	0	50	0	50	0	150	0	100%	0
5	50	0	50	0	50	0	150	0	100%	0
10	50	0	50	0	50	0	150	0	100%	0

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12	50	0	50	0	50	0	150	0	100%	0
16	24	26	24	26	25	25	73	77	48.7%	51.3%
20	0	50	0	50	0	50	0	150	0	100%
24	0	50	0	50	0	50	0	150	0	100%
30	0	50	0	50	0	50	0	150	0	100%
50	0	50	0	50	0	50	0	150	0	100%
100	0	50	0	50	0	50	0	150	0	100%

Urine Cassette format

hCGConcentration(mIU/mL)	Site 1		Site 2		Site 3		Total result		%Negative	%Positive
	-	+	-	+	-	+	-	+
0	50	0	50	0	50	0	150	0	100%	0
5	50	0	50	0	50	0	150	0	100%	0
10	50	0	50	0	50	0	150	0	100%	0
12	50	0	50	0	50	0	150	0	100%	0
16	25	25	24	26	22	28	71	79	47.3%	52.7%
20	0	50	0	50	0	50	0	150	0	100%
24	0	50	0	50	0	50	0	150	0	100%
30	0	50	0	50	0	50	0	150	0	100%
50	0	50	0	50	0	50	0	150	0	100%
100	0	50	0	50	0	50	0	150	0	100%

Cut-off values of 10 mIU/mL for serum and 20 mIU/mL for urine are established.

b. Stability

Stable at 4-30°C for 24 months based on the accelerated stability study at 50°C and real time stability determination at both 4℃ and 30℃.

c. Specificity / Cross Reactivity

High Dose Effect

Negative urine (serum) male samples were spiked with varying high hCG concentrations ranging from 62,500 to 2000,000 mIU/mL. The spiked samples were tested by 3 different lots and 3 different operators. No hook effect was observed at these concentrations

Effects of hCG ß-core fragment

Negative and positive samples (5 and 10 mIU/mL hCG in serum; 10 and 20 mIU/mL hCG in urine) were spiked with various concentrations of ß -core fragment hCG (0 to2x10 pmol/L). These samples were tested by 3 different lots and 3 different operators. No difference was observed for different lots and different operators. No interference was observed for these samples for the devices except that false positive was observed above the 200 pmol/L ß -core fragment hCG.

Effects of glycoprotein LH, FSH and TSH

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Negative and positive samples (10 and 20 mIU/mL hCG for urine, and 5 and 10 mIU/mL hCG for serum) were spiked with various concentrations of other glycoprotein hormones such as LH, FSH, and TSH. Samples were tested using three different lots by three operators. No interference was observed for these samples for the devices at LH concentrations up to 300 IU/mL, FSH concentrations up to 1000 mIU/mL, and TSH concentrations up to 1000 µIU/mL.

d. Interference

To evaluate potential interference from certain exogenous compounds, each interferent was made at 100X concentrate bulk and spiked in both hCG free and hCG positive (10mIU/mL for serum, 20mIU/mL for urine) samples. Each spiked urine sample was mixed for 5 minutes to ensure a homogeneous solution before testing. Each sample was tested using 3 different lots of the testing kit. Results are shown in the following table.

			3 minutes for urine (5 minutes for serum)			10 minutes
Interferents			Negative hCG	Positive hCG			Negative hCG			Positive hCG
	Lot	Lot	Lot	Lot	Lot	Lot	Lot	Lot	Lot	Lot	Lot	Lot
	1	2	3	1	2	3	1	2	3	1	2	3
Acetaminophen (20mg/dL)	-	-	-	+	+	+	-	-	-	+	+	+
Acetoacetic Acid (2000mg/dL)	-	-	-	+	+	+	-	-	-	+	+	+
Asorbic Acid (20mg/dL)	-	-	-	+	+	+	-	-	-	+	+	+
B-hydroxybutyrate(2000mg/dL)	-	-	-	+	+	+	-	-	-	+	+	+
Caffeine (20mg/dL)	-	-	-	+	+	+	-	-	-	+	+	+
Ephedrine (20mg/dL)	-	-	-	+	+	+	-	-	-	+	+	+
Gentisic Acid (20mg/dL)	-	-	-	+	+	+	-	-	-	+	+	+
Phenylpropanolamine(20mg/dL)	-	-	-	+	+	+	-	-	-	+	+	+
Salicylic Acid (20mg/dL)	-	-	-	+	+	+	-	-	-	+	+	+
Phenothiazine (20mg/dL)	-	-	-	+	+	+	-	-	-	+	+	+
EDTA (80mg/dL)	-	-	-	+	+	+	-	-	-	+	+	+
Acetylsalicylic Acid(20mg/dL)	-	-	-	+	+	+	-	-	-	+	+	+
Benzoylecgonine (10mg/dL)	-	-	-	+	+	+	-	-	-	+	+	+
Cannabinol (10mg/dL)	-	-	-	+	+	+	-	-	-	+	+	+
Codeine (6ug/dL)	-	-	-	+	+	+	-	-	-	+	+	+
Ethanol (1.0%)	-	-	-	+	+	+	-	-	-	+	+	+
Methanol (10%)	-	-	-	+	+	+	-	-	-	+	+	+
Albumin (2000mg/dL)	-	-	-	+	+	+	-	-	-	+	+	+
Glucose (2000mg/dL)	-	-	-	+	+	+	-	-	-	+	+	+
Bilirubin (2mg/dL)	-	-	-	+	+	+	-	-	-	+	+	+
Atropine (20mg/dL)	-	-	-	+	+	+	-	-	-	+	+	+
Estriol-17-beta (1400ug/dL)	-	-	-	+	+	+	-	-	-	+	+	+
Hemoglobin (2000mg/dL)	-	-	-	+	+	+	-	-	-	+	+	+

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Pregnanediol (1500ug/dL)	-	-	-	+	+	+	-	-	+	+
Thiophene (20mg/dl)	-	-	-	+	+	+	-	-	+	+
Ampicillin (20mg/dl)	-	-	-	+	+	+	-	-	+	+
Tetracycline(20mg/dl)	-	-	-	+	+	+	-	-	+	+
Cholesterol (250mg/dl)	-	-	-	+	+	+	-	-	+	+
Triglyceride (500mg/dl)	-	-	-	+	+	+	-	-	+	+
Lipoprotein (70mg/dl)	-	-	-	+	+	+	-	-	+	+
Ketone(20mg/dl)	-	-	-	+	+	+	-	-	+	+

All data show that there is no interference for the listed compounds at the stated concentrations.

e. Effect of Urine Specified Gravity and Urine pH

Negative and positive urine samples containing 10 and 20 mIU/mL hCG were tested at pH values from 4 to 9 or at density values ranging from 1.000 to1.035 using 3 different lots by 3 different operators. Data show that there is no interference from pH ranging from 4 to 9 and specific gravity ranging from 1.000 to 1.035 of tested urine samples.

2. Comparison Studies

A method comparison study was performed, comparing the results obtained from the Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette (Strip) to the results from predicate devices (QuickVue'). 120 each urine or serum samples were collected from 120 women (about half of them were pregnant, early stage at less than 5 weeks) from three testing sites. Samples were randomly collected at various times throughout the day. Ages ranged from 18 to 49 years. Samples were tested by six different health professionals with the proposed and the predicate devices at each site. Each person could only perform tests for one device format. For example, a person who tested the strips could not test the cassettes. Each person tested three different lots of the device and one predicate device at the same time, but not sequentially. Typical results are shown in the following tables.

Summary Results for Urine Strip

New Device	Cleared device		+	-
	+	60	0
-	0	60

Summary Results for Urine Cassette

New Device	Cleared device	+	-
	+	60	0
	-	0	60

Summary Results for Serum Strip

New Device	Cleared device
	+	-
+	60	0
-	0	60

Summary Results for Serum Cassette

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New Device	Cleared device	+	-
	+	60	0
-	0	60

The study result shows that 100% agreement for all samples.

1. Clinical Studies
  Not applicable
11.Conclusion
Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity and method comparison of the devices, it's concluded that Assure Tech hCG Pregnancy Serum/Urine Combo Test (Cassette, Strip) is substantially equivalent to the predicate.

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.