HIGHTOP Pregnancy Rapid Test Cassette is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.

HIGHTOP Pregnancy Rapid Test Strip is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.

HIGHTOP Pregnancy Rapid Test Midstream is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.

Device Description

HIGHTOP Pregnancy Rapid Test measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine for the detection of pregnancy. The test devices are in three different formats: Strip, Cassette and Midstream. Each test kit contains a test device sealed in a desiccated aluminum pouch and a package insert. The cassette format also contains a dropper.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting studies for the HIGHTOP Pregnancy Rapid Test devices, based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Analytical Sensitivity (Detection Limit)	25 mIU/mL (All three formats - Strip, Cassette, Midstream - achieved 100% positivity at 25 mIU/mL and 100% negativity at 18.75 mIU/mL in the sensitivity study.)
Hook Effect	No hook effect observed (No hook effect was observed at hCG concentrations ranging from 3125 to 2,000,000 mIU/mL.)
Specificity/Cross-Reactivity	No interference (No interference observed from 500 mIU/mL LH, 1000 mIU/mL FSH, 1000 mIU/L TSH, and 2,000,000 pmol/L hCG ß-core fragment for both negative and positive urine samples.)
Interfering Substances	No interference (No interferences observed from a comprehensive list of exogenous compounds at specified concentrations, changes in pH (4-9), or changes in specific gravity (1.002-1.032) for both negative and positive hCG urine samples.)
Method Comparison with Predicate Device	High Agreement (Over 96% agreement with the predicate device (WONDFO One Step HCG Urine Pregnancy Test - K043443) for all three formats. Specifically: - Strip: 57 positive, 0 false positive, 1 false negative, 62 true negative. - Cassette: 56 positive, 0 false positive, 2 false negative, 62 true negative. - Midstream: 57 positive, 0 false positive, 1 false negative, 62 true negative.)
Lay Person Readability & Usability	100% positive and negative conformity with professional results. (Lay person results showed 100% agreement with professional testing. Questionnaire results indicated consumers found the test easy to use and understood labeling/results.)
Shelf-Life Stability	24 months (Based on accelerated testing at 4-30°C in a sealed foil pouch. Real-time stability studies are ongoing.)

Study Details

2. Sample size used for the test set and the data provenance

Analytical Performance (Sensitivity):
- Test Set Sample Size: For each hCG concentration level (0, 12.5, 18.75, 22.5, 25, 50, 100, 200 mIU/mL), 50 replicates per lot across 3 lots = 150 total tests per hCG concentration. This was performed for each of the three device formats (Strip, Cassette, Midstream).
- Data Provenance: Negative urine was spiked with hCG standard. The specific origin of the negative urine or hCG standard is not explicitly stated beyond "traceable to the 5th WHO." This is an in-vitro study setup.
Hook Effect Test:
- Test Set Sample Size: Not explicitly stated as a count, but "Negative urine samples were spiked with varying hCG concentrations (3125, 6250, 62500, 125000, 250000, 500000, 1000000 and 2000000 mIU/mL)." Each concentration was tested to observe the effect.
- Data Provenance: In-vitro study setup using spiked urine samples.
Specificity and Cross-Reactivity:
- Test Set Sample Size: "Negative and positive urine samples (10 mIU/mL and 25 mIU/mL) were spiked with various concentrations of glycoprotein hormones LH, FSH, TSH and hCG ß-core fragment." The number of replicates is not specified.
- Data Provenance: In-vitro study setup using spiked urine samples.
Interfering Substance Test:
- Test Set Sample Size: "Urine samples containing 10 mIU/mL and 25 mIU/mL hCG were spiked with the interfering substance to obtain the desired test concentration" for a long list of substances, as well as pH and specific gravity variations. The number of replicates is not specified.
- Data Provenance: In-vitro study setup using spiked urine samples.
Method Comparison Study (with predicate device):
- Test Set Sample Size: 120 urine samples from women ("approximately half... suspected to be pregnant and most of them are in the early stage of less than 5 weeks").
- Data Provenance: Prospective collection from "women presenting to test for pregnancy at OB/GYN Physician's offices." The country of origin is not specified but implied to be where the offices are located. All samples were processed and tested after collection.
Lay Person Study:
- Test Set Sample Size: 300 women.
- Data Provenance: Prospective collection. "Women with varying educational and occupational backgrounds from three sites were chosen for the study." The country of origin is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Analytical Performance (Sensitivity): Ground truth was established by spiking known concentrations of hCG into negative urine. No human experts were involved in establishing this ground truth. However, "Tests were performed by three different operators" for reproducibility. Their qualifications are not specified.
Hook Effect Test, Specificity, Interfering Substances: Ground truth was established by spiking known concentrations of substances into urine. No human experts were involved in establishing this ground truth.
Method Comparison Study: Ground truth was established by the predicate device. "All samples were tested by ten different health professionals at the 3 OB/GYN Physician's offices with the proposed and the predicate devices." The qualifications of these "health professionals" are not specified beyond their title.
Lay Person Study: Ground truth was established by "professional testing with the candidate device." It is implied that "professional" here refers to trained personnel, likely the "health professionals" mentioned in the method comparison study. The qualifications of these professionals are not specified.

4. Adjudication method for the test set

Analytical Performance: The document describes "Total result" columns for '-' and '+' readings, implying a summation of results from different lots and operators. It doesn't describe an adjudication process for discordant results during the initial replicates, but the final % Negative / % Positive is presented as an aggregated outcome.
Method Comparison Study: No explicit adjudication method (e.g., 2+1, 3+1) is mentioned for resolving discrepancies between the proposed and predicate devices, or among the ten health professionals. The results are presented as direct comparison counts between the proposed device and the predicate device.
Lay Person Study: No explicit adjudication method is mentioned. Lay person results were compared to "professional testing with the candidate device," and a 100% conformity indicates no discrepancies needed adjudication, or any discrepancies were resolved outside of what is reported.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC study was not done, and this device is not an AI/CAD device. The studies described are for an in vitro diagnostic (IVD) pregnancy rapid test, which is a chemical assay read visually. There is no AI assistance involved with this device.

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

Yes, in essence, standalone performance was assessed though the term "standalone" is more common for AI algorithms. The analytical performance studies (sensitivity, hook effect, specificity, interfering substances) evaluate the device's inherent capability to detect/react to hCG under various conditions. The human role in these initial analytical tests is typically procedural (e.g., proper execution of the test, accurate reading of the results). The method comparison study and lay person study, while involving human readers (health professionals and lay users), assess the device's performance in the hands of users compared to another device or professional reading, rather than as an algorithm versus human.

7. The type of ground truth used

Analytical Performance Studies (Sensitivity, Hook Effect, Specificity, Interfering Substances): Spiked samples with known concentrations. This is a highly controlled, synthetic ground truth established in a lab setting.
Method Comparison Study: Ground truth was established by the predicate device (WONDFO One Step HCG Urine Pregnancy Test - K043443). This relies on the established accuracy of another legally marketed device.
Lay Person Study: Ground truth was established by professional testing with the candidate device. This relies on the deemed accurate interpretation by trained professionals using the same device.

8. The sample size for the training set

Not applicable. This device is a rapid diagnostic test based on immunochromatography, not an AI or machine learning model that requires a training set. The term "training set" is not relevant to the development and validation of this type of IVD.

9. How the ground truth for the training set was established

Not applicable. (See point 8 above).

Summary

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September 5, 2019

Qingdao Hightop Biotech Co., Ltd. % Joe Shia, Manager LSI International 504 E. Diamond Ave., Suite I Gaithersburg, MD 20877

Re: K192123

Trade/Device Name: HIGHTOP Pregnancy Rapid Test Cassette HIGHTOP Pregnancy Rapid Test Strip HIGHTOP Pregnancy Rapid Test Midstream Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: July 26, 2019 Received: August 6, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Kellie Kelm, Ph.D. Acting Director Division Director of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192123

Device Name HIGHTOP Pregnancy Rapid Test Cassette HIGHTOP Pregnancy Rapid Test Strip HIGHTOP Pregnancy Rapid Test Midstream

Indications for Use (Describe)

HIGHTOP Pregnancy Rapid Test Cassette is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.

HIGHTOP Pregnancy Rapid Test Strip is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.

HIGHTOP Pregnancy Rapid Test Midstream is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.

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

| | Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

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K192123 510(k) SUMMARY

1.	Date:	September 4, 2019
2.	Submitter:	Qingdao Hightop Biotech Co., Ltd.No.369 Hedong Road, Qingdao,Shandong, China 266112
3.	Contact person:	Joe ShiaLSI International Inc.504 East Diamond Ave., Suite JGaithersburg, MD 20877Telephone: 240-505-7880Fax: 301-916-6213Email:shiajl@yahoo.com
4.	Device Name:	HIGHTOP Pregnancy Rapid Test CassetteHIGHTOP Pregnancy Rapid Test MidstreamHIGHTOP Pregnancy Rapid Test Strip
	Classification:	Class II
	Product Code	LCX
	CFR	862.1155
5.	Predicate Devices:	WONDFO One Step HCG Urine Pregnancy Tes(K043443)

6. Device Description

7. Intended Use

HIGHTOP Pregnancy Rapid Test Cassette is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.

HIGHTOP Pregnancy Rapid Test Midstream is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.

HIGHTOP Pregnancy Rapid Test Strip is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.

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Similarities
Item	Candidate device	Predicate deviceK043443, WONDFO OneStep HCG Urine PregnancyTest
Intended use	Early detection ofpregnancy	Early detection ofpregnancy
Specimen	Urine	Urine
Assay technical	Immunochromatographicassay	Immunochromatographicassay
Sensitivity	25 mIU/mL	25 mIU/mL
Results	Qualitative	Qualitative
Target user	Over the counter use	Over the counter use
Device format	Strip, Cassette, Midstream	Strip, Cassette, Midstream
Reading Time	5 minutes	5 minutes

8. Substantial Equivalence Information

9. Test Principle

The test uses colloidal gold immunochromatography assay to detect human chorionic gonadotropin (hCG) in urine at cut-off 25 mIU/ml. When hCG concentration is higher than the cut-off, it will bind to rat anti ß-hCG monoclonal antibody which is labelled by colloidal gold. As the sample migrates on the nitrocellulose matrix of test strip by tomographic action, the complexes of detector antibody with B-hCG are separately captured to a-hCG antibody that has been immobilized on test strip, a red line appears in test zone (T) and the test result is positive. When hCG concentration is lower than the cut-off, there is no red line shows in test zone (T) and test result is negative. There is goat anti-mouse IgG polyclonal antibody immobilized in nitrocellulose filter membrane control zone (C) that bind to mouse anti a-hCG monoclonal antibody labelled by colloidal gold. When proper amount sample is applied a red line will appear in control zone (C).

10. Performance Characteristics

A. Analytical performance

a. Precision/Reproducibility/Sensitivity

Negative urine was spiked with hCG standard (traceable to the 5th WHO) to hCG concentrations of 0, 12.5, 18.75, 22.5, 25, 50, 100 and 200mIU/mL. The spiked

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samples were measured in replicates using 3 different lots for each format. Tests were performed by three different operators for each sample concentration in 10 runs per day for 5 days. The results are summarized in the table below:

Strip format

hCGConcentration(mIU/mL)	Lot 1		Lot 2		Lot 3		Total result		% Negative	% Positive
	-	+	-	+	-	+	-	+
0	50		50		50		150		100%
12.5	50		50		50		150		100%
18.75	50		50		50		150		100%
22.5	23	27	25	25	23	27	71	79	47.33%	52.67%
25		50		50		50		150		100%
50		50		50		50		150		100%
100		50		50		50		150		100%
200		50		50		50		150		100%

Cassette format

hCGConcentration(mIU/mL)	Lot 1		Lot 2		Lot 3		Total result		%Negative	%Positive
	-	+	-	+	-	+	-	+
0	50		50		50		150		100%
12.5	50		50		50		150		100%
18.75	50		50		50		150		100%
22.5	26	24	24	26	26	24	76	74	50.67%	49.33%
25		50		50		50		150		100%
50		50		50		50		150		100%
100		50		50		50		150		100%
200		50		50		50		150		100%

Midstream format

hCGConcentration(mIU/mL)	Lot 1		Lot 2		Lot 3		Total result		%Negative	%Positive
	-	+	-	+	-	+	-	+
0	50		50		50		150		100%
12.5	50		50		50		150		100%
18.75	50		50		50		150		100%
22.5	26	24	24	26	25	25	75	75	50%	50%
25		50		50		50		150		100%
50		50		50		50		150		100%
100		50		50		50		150		100%
200		50		50		50		150		100%

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Based on the above results, the sensitivity of HIGHTOP Pregnancy Rapid Test is demonstrated to be 25 mIU/mL.

b. Linearity/assay reportable range:

Linearity is not applicable since this is a qualitative test.

c. Hook effect test:

Negative urine samples were spiked with varying hCG concentrations (3125, 6250, 62500, 125000, 250000, 500000, 1000000 and 2000000 mIU/mL). All tested concentrations gave a positive result. The results demonstrated that no hook effect was observed at hCG concentrations ranging from 3125 to 2000000 mIU/mL.

d. Traceability, Stability, Expected values (controls, calibrators, or methods): HIGHTOP Pregnancy Rapid Test is calibrated against reference material traceable to WHO International Standard 5th edition.

A shelf-life stability test of the devices was performed by accelerated testing. The results showed that the devices were stable for 24 months when stored at 4~30℃ in the sealed foil pouch. Real time stability studies are ongoing.

e. Specificity and cross reactivity

To evaluate specificity and cross-reactivity, negative and positive urine samples (10 mIU/mL and 25 mIU/mL) were spiked with various concentrations of glycoprotein hormones LH, FSH, TSH and hCG ß-core fragment. The results showed that there is no interference at 500 mIU/mL LH, 1000 mIU/mL FSH, 1000 mIU/L TSH and 2,000,000 pmol/L hCG ß-core fragment for both negative and positive urine samples.

f. Interfering substance

To evaluate the potential for interference by certain exogenous compounds, each interfering substance was prepared by diluting stock interfering material to the desired concentration. Urine samples containing 10 mIU/mL and 25 mIU/mL hCG were spiked with the interfering substance to obtain the desired test concentration. No interferences were observed from exogenous compounds at the following concentrations for both negative and positive hCG urine samples.

Substances	Concentration
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

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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	500mg/dL
Pregnanediol	1500ug/dL
Thiophene	20mg/dl
Ampicillin	20mg/dl
Tetracycline	20mg/dl
Ketone	20mg/dl

To evaluate potential interference from changes in pH, urine samples containing 10 mIU/mL and 25 mIU/mL hCG were tested at pH values of 4, 5, 6, 7, 8 and 9. The results indicated that changes in pH range of 4~9 do not interfere in the results that were either positive or negative for hCG.

To evaluate potential interference from changes in specific gravity, urine samples containing 10 mIU/mL and 25 mIU/mL hCG were tested at density values ranging from 1.002, 1.009, 1.012, 1.018, 1.028 and 1.032. The results indicated that changes in specific gravity do not interfere in the results that were either positive or negative for hCG.

B. Method comparison study

Method comparison with predicate device

The performance of the new device was compared to the predicate test. Urine samples were collected from 120 women presenting to test for pregnancy at OB/GYN Physician's offices. Approximately half of the 120 women were suspected to be pregnant and most of them are in the early stage of less than 5 weeks. All samples were stored in refrigerators after collection and prior to testing by health professionals. All samples were tested by ten different health professionals at the 3 OB/GYN Physician's offices with the proposed and the predicate devices.

Strip Format		Predicate device
		Positive	Negative
HIGHTOP RapidPregnancy Test	Positive	57	0
	Negative	1	62

	Cassette	Predicate device
--	----------	------------------

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		Positive	Negative
HIGHTOP RapidPregnancy Test	Positive	56	0
	Negative	2	62

Midstream		Predicate device
		Positive	Negative
HIGHTOP RapidPregnancy Test	Positive	57	0
	Negative	1	62

The above results indicate an over 96% agreement between the proposed and the predicate.

C. Lay person study:

300 women's individual pregnancy status was self-tested. Women with varying educational and occupational backgrounds from three sites were chosen for the study. Each subject tested her own urine sample using the candidate device according to the package insert. Each subject also provided a sample for professional testing with the candidate device as well.

HIGHTOP Pregnancy Rapid Test Strip	Professional
	+	-
Lay person	+	49	0
	-	0	51

HIGHTOP Pregnancy Rapid Test Cassette	Professional
	+	-
Lay person	+	47	0
	-	0	53

HIGHTOP Pregnancy Rapid Test Midstream	Professional
	+	-
Lay person	+	52	0
	-	0	48

From the above tables, the lay person results showed 100% positive and negative conformity with the professional results.

Each lay person was given a questionnaire to assess the readability of the labeling. The results of the questionnaire reflected that the consumers found the test easy to

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use and that they did not have trouble understanding the labeling and interpreting the results.

11. Conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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.