The Altest Pregnancy Rapid Combo Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum to aid in the early detection of pregnancy. The test is for health care professionals use including professionals at point of care (POC).

Device Description

The Alltest Pregnancy Rapid Combo Test Cassette 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 device is used as a single cassette device.

AI/ML Overview

The provided document is a 510(k) summary for the Alltest Pregnancy Rapid Combo Test Cassette, which is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum to aid in the early detection of pregnancy. The device is intended for prescription use by healthcare professionals, including those at the point of care.

Here's an analysis of the acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a separate section with predefined thresholds. Instead, it presents performance data from various studies. Based on the "Performance Characteristics" section, the implicit acceptance criteria are that the device should demonstrate:

High precision and accuracy around the cut-off values.
Stability over an extended period.
Specificity, with no significant interference from related hormones or common substances.
No high-dose hook effect.
Performance comparable to a legally marketed predicate device.

The reported device performance aligns with these implicit criteria, indicating successful validation.

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Precision/Cut-Off	Establish accurate cut-off values (10 mIU/mL for serum, 20 mIU/mL for urine) with consistent positive/negative results across sites, lots, and operators.	* Serum: At 8 mIU/mL (below cut-off), 75.6% positive. At 10 mIU/mL (cut-off), 100% positive. At 0, 3, 5 mIU/mL, 100% negative. At concentrations >= 10 mIU/mL, 100% positive. * Urine: At 15 mIU/mL (below cut-off), 48.9% positive. At 17.5 mIU/mL (below cut-off), 80% positive. At 20 mIU/mL (cut-off), 100% positive. At 0, 5, 10 mIU/mL, 100% negative. At concentrations >= 20 mIU/mL, 100% positive. * Conclusion: Cut-off values of 10 mIU/mL for serum and 20 mIU/mL for urine are verified.
Stability	Demonstrate stability for an appropriate shelf life under specified storage conditions.	Stable at 2-30°C for 24 months based on an accelerated stability study at 55°C.
Specificity (High Dose Effect)	No hook effect at high hCG concentrations.	No hook effect observed with hCG concentrations ranging from 500 to 2,000,000 mIU/mL.
Specificity (ß-core fragment)	No significant interference from hCG ß-core fragment up to certain concentrations.	No interference observed except for false positives above 100 pmol/L ß-core fragment hCG. (Note: The document doesn't provide the expected range of ß-core fragment in actual samples or how this level of interference compares to clinical relevance, but states "No difference was observed for different lots and different operators.")
Specificity (Glycoprotein Hormones)	No interference from LH, FSH, TSH at physiological/elevated levels.	No interference observed at LH concentrations up to 500 IU/mL, FSH concentrations up to 1000 mIU/mL, and TSH concentrations up to 1000 uIU/mL.
Interference (Common Substances)	No interference from a specified list of common exogenous and endogenous substances at given concentrations.	All tested compounds (Acetaminophen, Acetoacetic Acid, Ascorbic Acid, Atropine, Acetosalicylic Acid, Albumin, Bilirubin, Caffeine, Codeine, Ephedrine, EDTA, Ethanol, Gentisic Acid, Glucose, Hemoglobin, Methadone, Phenylpropanolamine, Phenothiazine, Pregnanediol, Salicylic Acid, ß-hydroxybutyrate, Benzoylecgonine, Cannabinol, Methanol, Estriol-17-beta, Thiophene, Ampicillin, Tetracycline, Ketone, Total cholesterol, Triglycerides, High-density lipoprotein) showed no interference at the stated concentrations for both negative and positive hCG samples.
Effect of Urine Specific Gravity & pH	No interference across physiological/pathological ranges of urine specific gravity and pH.	No interference from pH ranging from 4 to 9 and specific gravity ranging from 1.001 to 1.035.
Method Comparison	Demonstrate substantial equivalence (high agreement) with a legally marketed predicate device.	* Urine: 100% agreement between the new device and the predicate (53 positive, 52 negative). * Serum: 100% agreement between the new device and the predicate (58 positive, 49 negative).

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

Precision/Reproducibility/Cut-Off Value Study:
- Test Set Size (Serum): 90 replicates for each hCG concentration level (3 sites x 30 replicates per concentration). In total, 9 concentrations were tested, so 90 x 9 = 810 tests.
- Test Set Size (Urine): 90 replicates for each hCG concentration level (3 sites x 30 replicates per concentration). In total, 9 concentrations were tested, so 90 x 9 = 810 tests.
- Data Provenance: Not explicitly stated, but the testing was conducted at "three testing sites" by "six different operators." It's likely these were internal or contract labs, possibly within China (where the manufacturer is located) or the US (where the submitter's contact is). The data is from controlled experimental studies.
- Retrospective/Prospective: Prospective (experimental spiking of samples).
Method Comparison Study:
- Test Set Size (Urine): 105 urine samples.
- Test Set Size (Serum): 107 serum samples.
- Total Test Set Size: 212 samples (from 212 women).
- Data Provenance: Samples collected from 212 women from "three testing sites." Ages ranged from 20 to 49 years. "About half of them were pregnant, early stage at less than 5 weeks." Not explicitly stated, but implies clinical samples used for comparison. The country of origin is not specified.
- Retrospective/Prospective: Likely prospective clinical sample collection for the purpose of the study.
Other Analytical Performance Studies (Specificity, Interference, pH/Specific Gravity):
- Sample sizes vary but generally involve spiking negative and positive samples with various concentrations of the interferent/condition and testing with 3 different lots by 3 different operators. Exact total sample counts for each condition are not explicitly provided but involve multiple replicates across lots and operators.
- Data Provenance: Controlled experimental studies with spiked samples.
- Retrospective/Prospective: Prospective (experimental spiking of samples).

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

Precision/Reproducibility/Cut-Off Value Study: The "ground truth" for the test set was established by precisely spiking known concentrations of hCG (traceable to the 5th WHO international Standard) into negative serum or urine specimens. This is an analytical truth rather than an expert interpretation. Six different operators performed these tests; their qualifications are not specified but would typically be laboratory technicians.
Method Comparison Study:
- The "ground truth" for the comparison study was the result obtained from the predicate device (K132834, Clarity Diagnostics Clarity hCG Pregnancy Combo Test Cassette). This means the predicate device itself served as the reference standard, and the new device's agreement was measured against it.
- There is no mention of independent experts establishing a "true" pregnancy status. The comparison is between two devices.
- The tests were performed by "different health professionals," but their specific number or qualifications (e.g., radiologist with 10 years of experience) are not provided.

4. Adjudication Method for the Test Set

Precision/Reproducibility/Cut-Off Value Study: No adjudication method as the ground truth was analytically determined (spiked concentrations). Results were recorded and analyzed statistically.
Method Comparison Study: No adjudication method mentioned for comparing the predicate and new device results against a separate "true" outcome. The comparison itself uses the predicate device as the reference.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document describes the performance of an in-vitro diagnostic (IVD) test, not an imaging device or AI-powered diagnostic that would typically involve human readers interpreting cases with and without AI assistance. Therefore, an MRMC comparative effectiveness study was not performed, and there is no effect size reported for human readers improving with AI vs. without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in essence. The studies present the analytical performance of the device itself (the "algorithm" or immunoassay), reporting its ability to detect hCG in various conditions. While "health professionals" perform the tests, the core performance characteristics (sensitivity, specificity, cut-off accuracy, interference) are inherent to the device's design and chemical reactions, operating in a standalone manner once the sample is applied. The "Method Comparison Study" directly evaluates the standalone performance of the device against another device.

7. Type of Ground Truth Used

Analytical Studies (Precision, Specificity, Interference, pH/Specific Gravity): The ground truth was based on known, precisely controlled concentrations of hCG, interferents, or specific pH/gravity conditions, established through spiking or preparing samples. This is a form of analytical truth.
Method Comparison Study: The ground truth for this study was the results obtained from a legally marketed predicate device. The predicate device's results were accepted as the reference against which the new device was compared.

8. Sample Size for the Training Set

This document primarily describes analytical validation and comparison studies. For an IVD device like this, there isn't typically a "training set" in the machine learning sense. The device's performance is driven by its biochemical design and manufacturing process, not trained on data. Development may involve iterative testing and refinement, but a formal "training set" size as understood in AI/ML is not applicable or provided here.

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

As noted above, a "training set" in the context of AI/ML is not applicable for this type of immunoassay device. The device's operational parameters (like antibody conjugates, membrane properties, and cut-off thresholds) are established through research, development, and analytical validation studies, not by training on a labeled dataset.

Summary

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January 31, 2022

Hangzhou AllTest Biotech Co., Ltd % Joe Shia Director LSI International Inc 504E Diamond Ave, Suite J Gaithersburg, Maryland 20877

Re: K203272

Trade/Device Name: Alltest Pregnancy Rapid Combo Test Cassette Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System Regulatory Class: Class II Product Code: JHI Dated: November 1, 2021 Received: November 2, 2021

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 (QS) 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,

Marianela Perez-Torres, Ph.D. Deputy Director Division 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) K203272

Device Name Alltest Pregnancy Rapid Combo Test Cassette

Indications for Use (Describe)

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

☑ Prescription Use (Rx) (21 CFR 201.100(b))	☐ Over-The-Counter Use (21 CFR 201.66)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY K203272

1. Date:	December 23, 2021
2. Submitter:	Hangzhou AllTest Biotech Co., Ltd.No. 550, Yinhai StreetHangzhou, China, 310018
3. Contact person:	Joe ShiaLSI International Inc.504 East Diamond Ave., Suite IGaithersburg, MD 20877Telephone: 240-505-7880Fax: 301-916-6213Email:shiajl@yahoo.com

1. Device Name: Alltest Pregnancy Rapid Combo Test Cassette
  Classification: ClassII

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

1. Predicate Devices:
  K132834, Clarity Diagnostics Clarity hCG Pregnancy Combo Test Cassette
1. Intended Use
  The Alltest Pregnancy Rapid Combo Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum to aid in the early detection of pregnancy.

The test is for health care professionals use including professionals at point of care (POC).

1. Device Description
  The Alltest Pregnancy Rapid Combo Test Cassette 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 device is used as a single cassette device.
1. Substantial Equivalence Information

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A summary comparison of features of the Alltest Pregnancy Rapid Combo Test Cassette and the predicate device is provided in the following table.

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 minutes Urine:3 minutes	5 minutes for bothserum and urine
Usage	For prescription use	Same
Cut-Off Values	10 mIU/mL for serum and 20mIU/mL for urine	Same
Configurations	Cassette	Same
Storage	2 – 30°C	Same

9. Test Principle

It is a lateral flow chromatographic immunoassay. When a sample is added, the sample is absorbed into the device by capillary action and mixes with the antibodydye conjugate (mouse anti-beta HCG monoclonal antibody), flowing across the precoated (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.

10. Performance Characteristics

Analytical Performance

a. Precision/Reproducibility/Cut-Off Value
Negative serum or urine specimens were spiked with varying hCG (commercially available and traceable to the 5th WHO international Standard) concentrations. The spiked samples were measured in 6 replicates each day for 5 days using 3 different lots at three testing sites. Tests were performed by six different operators for each sample concentration. Results are shown in the following tables.

hCGConcentration	Site 1Lot 2	Site 2Lot 3	Site 3Lot 1	Totalresult	%Negative	%Positive
----------------------	-----------------	-----------------	-----------------	-----------------	---------------	---------------

Serum

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(mIU/mL)	-	+	-	+	-	+	-	+	-	+
0	30	0	30	0	30	0	90	0	100	0
3	30	0	30	0	30	0	90	0	100	0
5	30	0	30	0	30	0	90	0	100	0
8	7	23	7	23	8	22	22	68	24.4	75.6
10	0	30	0	30	0	30	0	90	0	100
12	0	30	0	30	0	30	0	90	0	100
15	0	30	0	30	0	30	0	90	0	100
20	0	30	0	30	0	30	0	90	0	100
50	0	30	0	30	0	30	0	90	0	100

Urine

hCGConcentration(mIU/mL)	Site 1Lot 2		Site 2Lot 3		Site 3Lot 1		Totalresult		%Negative	%Positive
	-	+	-	+	-	+	-	+
0	30	0	30	0	30	0	90	0	100	0
5	30	0	30	0	30	0	90	0	100	0
10	30	0	30	0	30	0	90	0	100	0
15	15	15	16	14	15	15	46	44	51.1	48.9
17.5	6	24	6	24	6	24	18	72	20	80
20	0	30	0	30	0	30	0	90	0	100
30	0	30	0	30	0	30	0	90	0	100
50	0	30	0	30	0	30	0	90	0	100
100	0	30	0	30	0	30	0	90	0	100

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

b. Stability

Stable at 2-30°C for 24 months based on the accelerated stability study at 55°C.

c. Specificity / Cross Reactivity

High Dose Effect

Negative urine (serum) samples were spiked with varying high hCG concentrations ranging from 500 to 2,000,000 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 to 2x106pmol/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 100 pmol/L ß -core fragment hCG.

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Effects of glycoprotein LH, FSH and TSH

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 device at LH concentrations up to 500 IU/mL, FSH concentrations up to 1000 mIU/mL, and TSH concentrations up to 1000 uIU/mL.

d. Interference

To evaluate potential interference from certain exogenous compounds, each interferent was made at 100X concentrate bulk and spiked in both hCG negative (5mIU/mL for serum, 10mIU/mL for urine) 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.

Interferents	Concentration	Negative hCG			Positive hCG
		Lot1	Lot2	Lot3	Lot1	Lot2	Lot3
Acetaminophen	20 mg/dl	-	-	-	+	+	+
Acetoacetic Acid	2000 mg/dl	-	-	-	+	+	+
Ascorbic Acid	20 mg/dl	-	-	-	+	+	+
Atropine	20 mg/dl	-	-	-	+	+	+
Acetosalicylic Acid	20 mg/dl	-	-	-	+	+	+
Albumin	2000mg/dl	-	-	-	+	+	+
Bilirubin	2mg/dl	-	-	-	+	+	+
Caffeine	20 mg/dl	-	-	-	+	+	+
Codeine	10mg/dl	-	-	-	+	+	+
Ephedrine	20 mg/dl	-	-	-	+	+	+
EDTA	80 mg/dl	-	-	-	+	+	+
Ethanol	1%	-	-	-	+	+	+
Gentisic Acid	20 mg/dl	-	-	-	+	+	+
Glucose	2000mg/dl	-	-	-	+	+	+
Hemoglobin	2000mg/dl	-	-	-	+	+	+
Methadone	10mg/dl	-	-	-	+	+	+
Phenylpropanolamine	20 mg/dl	-	-	-	+	+	+
Phenothiazine	20 mg/dl	-	-	-	+	+	+
Pregnanediol	1.5 mg/dl	-	-	-	+	+	+
Salicylic Acid	20 mg/dl	-	-	-	+	+	+
B-hydroxybutyrate	2000mg/dL	-	-	-	+	+	+
Benzoylecgonine	10mg/dL	-	-	-	+	+	+
Cannabinol	10mg/dL	-	-	-	+	+	+
Methanol	10%	-	-	-	+	+	+

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Estriol-17-beta	1.4mg/dL	-	-	-	+	+	+
Thiophene	20mg/dl	-	-	-	+	+	+
Ampicillin	20mg/dl	-	-	-	+	+	+
Tetracycline	20mg/dl	-	-	-	+	+	+
Ketone	20mg/dl	-	-	-	+	+	+
Total cholesterol (serum only )	250mg/dl	-	-	-	+	+	+
Triglycerides (serum only )	1200mg/dl	-	-	-	+	+	+
High-density lipoprotein (serum only)	70mg/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 1.001 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 1.001 to 1.035 of tested urine samples.

2. Comparison Studies

A method comparison study was performed, comparing the results obtained from the Alltest hCG Pregnancy Rapid Combo Test Cassette to the results from predicate devices (K132834). 105 urine and 107 serum samples were collected from 212 women (about half of them were pregnant, early stage at less than 5 weeks) from three testing Samples were randomly collected at various times throughout the day. Ages sites. ranged from 20 to 49 years. Samples were tested by different health professionals with the proposed and the predicate devices at each site. The obtained results are shown in the following tables.

Summary Results for Urine Cassette

New Device	Cleared device
	+	-
+	53	0
-	0	52

Summary Results for Serum Cassette

	Cleared device	+	-
New Device	+	58	0
	-	0	49

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

1. Clinical Studies
  Not applicable

11.Conclusion

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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 Alltest hCG Pregnancy Serum/Urine Combo Test Cassette 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.