TrueDx™ hCG Early Result Pregnancy Test (Midstream & Cassette Formatographic immunoassay for qualitative detection of human chorionic (hCG) in urine, as an in aid in early detection of pregnancy, in some case as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.

VeriClear™ Early Result Pregnancy Test (Midstream & Cassette Formatographic immunoassay for qualitative detection of human chorionic (hCG) in urine, as an in aid in early detection of pregnancy, in some case as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.

Device Description

TrueDX™ hCG Early Result Pregnancy Test is designed to be tested in midstream and cassette mode. Each of the devices (Cassette and Midstream), contains a pouch with the test and instructions for use. The cassette and midstream nitrocellulose test strips are contained in a plastic housing. The cassette test also contains a dropper.

TrueDX™ hCG Early Result Pregnancy Test is a qualitative lateral flow immunoassay for the detection of hCG. The device comes in two formats: Cassette and Midstream. Each device includes a pouch with the all components to perform the test, instruction for use and a desiccant package to control the moisture during the storage of the test kit. The cassette and midstream nitrocellulose test strips are mounted in a plastic housing. The cassette test, which is designed to be used as prescription use contains a dropper pipette.

The VeriClear™ Early Result Pregnancy Test and TrueDX™ hCG Early Result Pregnancy Test are the same devices, except the device names and intended use population.

AI/ML Overview

The provided document is a 510(k) Summary for the TrueDX™ hCG Early Result Pregnancy Test and VeriClear™ Early Result Pregnancy Test, which are qualitative chromatographic immunoassays for the detection of human chorionic gonadotropin (hCG) in urine. The document details the device's performance characteristics, including analytical and clinical studies.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied rather than explicitly stated as quantitative targets in a table within this summary document for certain aspects. However, for analytical sensitivity, a clear target is indicated. For other performance metrics, the "acceptance" is demonstrated by the reported results showing highly accurate and consistent performance, often achieving 100% agreement or detection at specified levels.

Here's a table summarizing the acceptance criteria (inferred or explicitly stated) and the reported device performance:

Acceptance Criterion (Inferred/Stated)	Reported Device Performance (Midstream and Cassette formats unless specified)
Analytical Performance
Precision/Reproducibility (Across Lots) (0, 3, 5 mIU/ml hCG: 0% positive) (10, 25, 50, 100 mIU/ml hCG: 100% positive)	Midstream: 0, 3, 5 mIU/ml: 0/250 positive (0%) for all lots. 10, 25, 50, 100 mIU/ml: 250/250 positive (100%) for all lots. Cassette: 0, 3, 5 mIU/ml: 0/250 positive (0%) for all lots. 10, 25, 50, 100 mIU/ml: 250/250 positive (100%) for all lots. (8.5 mIU/ml showed ~50% positivity, as expected for a concentration near the detection limit).
Precision/Reproducibility (Across Operators) (0, 3, 5 mIU/ml hCG: 0% positive) (10, 25, 50, 100 mIU/ml hCG: 100% positive)	Midstream: 0, 3, 5 mIU/ml: 0/150 positive (0%) for all operators. 10, 25, 50, 100 mIU/ml: 150/150 positive (100%) for all operators. Cassette: 0, 3, 5 mIU/ml: 0/150 positive (0%) for all operators. 10, 25, 50, 100 mIU/ml: 150/150 positive (100%) for all operators. (8.5 mIU/ml showed ~50% positivity, as expected).
Within-Lot Reproducibility (0, 3, 5 mIU/ml hCG: 0% positive) (10, 25, 50, 100 mIU/ml hCG: 100% positive)	All Formats (Simulate Stream, Midstream Dip, Cassette): 0, 3, 5 mIU/ml: 20/20 negative (100%) for all. 10, 25, 50, 100 mIU/ml: 20/20 positive (100%) for all. (8.5 mIU/ml showed ~55% positivity, as expected).
Analytical Sensitivity / Detection Limit (Lowest concentration yielding 100% positive results should be relevant to early pregnancy claims, e.g., 10 mIU/ml)	10 mIU/ml (lowest concentration that yields 100% positive results for both formats across lots and operators).
Analytical Specificity (Interference) (No interference from common substances at specified concentrations in negative and 10 mIU/ml hCG samples)	No interfering impact observed for all substances listed (e.g., Acetaminophen, Aspirin, Caffeine, etc.) at their highest tested concentrations, for both negative and 10 mIU/ml hCG.
Analytical Specificity (Cross-reactivity) (No cross-reactivity with hLH, hFSH, hTSH at high concentrations)	No cross-reactivity observed with 1000 mIU/ml hLH, 1000 mIU/ml hFSH, and 1000 µIU/ml hTSH for both formats.
Cross-reactivity with Hyper-glycosylated hCG	All replicates tested with H. hCG standards at above 0.0147 µg/L (5.8 mIU/ml) yielded positive results, demonstrating expected reactivity.
Effect of Urine pH (Results not affected by pH 4.0-9.0)	Positive and negative hCG results were not affected by urine pH levels between 4.0 and 9.0.
Effect of Urine Specific Gravity (Results not affected by specific gravity 1.000-1.035)	Positive and negative hCG results were not affected by urine specific gravity concentrations between 1.000 and 1.035.
High Dose Hook Effect (No hook effect up to high hCG concentrations)	No hook effect observed at hCG concentrations up to 450,000 mIU/ml.
Effect of hCG β-core fragment (No interference from high levels of β-core fragment)	Concentration of hCG beta core fragment up to 408,000 pmole/L yielded correct results.
Method Comparison with Predicate Device (High concordance with predicate device)	65/65 positive and 101/101 negative agreement between candidate device and predicate device (100% agreement for both positive and negative samples).
Clinical Performance (Early Pregnancy Detection) (Detection rates days before missed period consistent with claims)	-5 days before expected period: 71% detection; -1 day before expected period: 100% detection.
Lay User Performance (High agreement with professional users and correct interpretation)	Lay user vs. Professional (Actual Urine): Pregnant: 9/9 agreement (Midstream), 9/9 agreement (Midstream-Dip), 6/6 agreement (Cassette). Non-pregnant: 101/101 agreement (Midstream), 101/101 agreement (Midstream-Dip), 102/102 agreement (Cassette). Lay user vs. Professional (Spiked Urine for Analytical Sensitivity): 3 mIU/ml: 100% agreement (0 positives for both). 10 mIU/ml: 100% agreement (100% positives for both). (8.5 mIU/ml agreement: 96-97%).
Specificity Study (False Positives in Non-Pregnant Women) (No false positives in non-pregnant women across age groups)	0 false positives out of 320 non-pregnant women (100 pre-menopausal, 111 peri-menopausal, 109 post-menopausal).
Shelf Life	A 24-month shelf life claimed and supported by stability testing.

2. Sample sizes used for the test set and data provenance:

Precision/Reproducibility:
- Across Lots: 250 replicates per hCG level per lot (10 replicates/run x 5 operators x 5 days). Total of 750 replicates per hCG level for 3 lots.
- Across Operators: 150 replicates per hCG level per operator (from the above dataset).
Within-Lot Reproducibility: 20 replicates for each hCG level.
Analytical Sensitivity: 15 replicates per hCG concentration per lot. Total of 45 replicates per hCG concentration for 3 lots.
Analytical Specificity (Interference): At least 2 replicates (implied by "2 different lots") per substance for negative and 10 mIU/ml hCG samples. ("All samples were tested in replicates of 5 for each format" is also stated later, suggesting maybe 5 replicates per lot per sample type.)
Cross-reactivity: Replicates for each substance (number not explicitly stated, but "tested by two operators with two lots of the test kit for each format" implies multiple tests). For hyper-glycosylated hCG, 5 replicates per hCG concentration for 3 different lots.
pH/Specific Gravity/Hook Effect/β-core Fragment: Replicates tested (number not always explicitly stated, but implied as sufficient for robust testing). For hook effect, 3 lots tested by 2 operators.
Method Comparison with Predicate Device: 166 urine samples from women at physician offices.
Clinical Samples (Early Pregnancy Detection): 616 urine samples from 56 different women.
Lay User Study:
- Actual Urine: 218 females tested their own urine (110 Midstream, 108 Cassette). 9 pregnant, 101 non-pregnant for Midstream/Midstream-Dip; 6 pregnant, 102 non-pregnant for Cassette.
- Spiked Urine: 53 samples at each hCG level for Midstream, 57 for Midstream-Dip, and 110 for Cassette.
Specificity Study (False Positives in Non-Pregnant Women): 320 non-pregnant women (100 pre-menopausal, 111 peri-menopausal, 109 post-menopausal).

Data Provenance:
The document does not explicitly state the country of origin for the data. The studies are described as internal performance evaluations. While patient samples were collected from "physician offices" and "women who planned to become pregnant," the document doesn't specify if these were prospective or retrospective collections, though the early pregnancy detection study following women throughout their conception cycles sounds prospective for that specific cohort. The lay user study involved participants with diverse backgrounds recruited specifically for the study, suggesting a prospective design for that component.

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

The document describes the device as measuring hCG levels, where hCG is a biological marker. Ground truth for hCG levels in urine samples for the analytical studies (precision, sensitivity, specificity) was established by spiking known concentrations of hCG standard traceable to the WHO 4th International Standard, or by using known negative urine samples. These are objective, quantitative measures rather than observer-dependent expert interpretations.

For the method comparison study, the predicate device was presumably used as the reference standard, and the results of both the candidate and predicate devices were compared. The text states "Urine samples were collected from 166 women at physician offices for pregnancy testing," and the samples were "masked and randomized." All samples were tested by "two different health care professionals." Their specific qualifications are not detailed beyond "health care professionals."

For the clinical sample (early pregnancy detection) study, samples were collected from women followed throughout their conception cycles. The ground truth for pregnancy status and relative timing to the expected menstrual period (EMP) would be clinical, likely based on confirmed pregnancy outcomes and menstrual cycle tracking. The document implies that the detection rate is against the true biological state rather than expert interpretation of the test result itself.

For the lay user study, professional users also tested aliquots of the same urine samples as a reference for comparison, implying their results served as a ground truth for interpretation consistency. Their qualifications are not specified beyond "professional."

For the specificity study to determine false-positive rates, an "ELISA quantitative analyzed hCG level test kit" was used as the reference method ("ground truth") to confirm hCG levels, and subjects with positive results on the new device or hCG levels >5.00 mIU/ml on ELISA were referred for "clinical confirmation of positive." This implies a multi-modal ground truth involving an objective lab assay and clinical follow-up.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Adjudication methods (like 2+1, 3+1 for consensus readings) are typically used in image-based AI studies where human interpretation is the primary ground truth. This is an hCG urine test kit.

For analytical studies, the "ground truth" is the known spiked concentration or the characterized negative sample. No adjudication is needed as the result is objectively positive/negative based on the strip's reaction.
For the precision study, multiple operators tested replicates, and the results were aggregated to calculate reproducibility (e.g., % positive). This is a statistical aggregation, not adjudication.
For the method comparison study, each sample was tested by "two different health care professionals." It's not stated whether there was an adjudication rule if their interpretations differed; given it's a qualitative test (positive/negative), disagreements would likely be rare or require re-testing/third party confirmation. The 100% agreement reported suggests no significant discrepancies needed formal adjudication.
For the lay user study, lay user results were compared to professional user results. Discrepancies (e.g., 8 lay users positive vs. 9 professional positive for 7.0mIU/ml, or 30 vs 32 for 8.5mIU/ml) are simply reported as the difference in numbers/percentages, indicating performance deviation, not an adjudication process to force agreement.

Therefore, formal adjudication as typically understood in reader studies was not applicable or explicitly described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size:

No, an MRMC study was not done. MRMC studies are primarily for evaluating the impact of AI on human reader performance in diagnostic imaging by measuring reader accuracy with and without AI assistance across multiple cases and readers. This document describes a standalone in-vitro diagnostic (IVD) test kit, not an AI-powered diagnostic tool for human interpretation.

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

Yes, the device is inherently a standalone chemical assay that produces a visual result. The various analytical and clinical studies described (precision, sensitivity, specificity, early pregnancy detection with clinical samples, false-positive rate) demonstrate the "algorithm only" performance (i.e., the device's performance as an assay) without human-in-the-loop assistance influencing the outcome of the test itself. The lay user study primarily evaluates ease of use and interpretation accuracy by lay users rather than an assisted vs. unassisted performance comparison.

7. The type of ground truth used:

Analytical Studies (Precision, Sensitivity, Specificity): Primarily known spiked concentrations of hCG standard (traceable to WHO 4th International Standard) in negative human urine, and characterized negative urine samples. This is a form of reference standard/laboratory-defined ground truth.
Method Comparison: Comparison against a legally marketed predicate device (FIRST RESPONSE Early Result Pregnancy Test) on collected urine samples. The predicate device's result serves as the de-facto ground truth for equivalence.
Early Pregnancy Detection Clinical Samples: Likely clinical confirmation of pregnancy (e.g., blood tests, ultrasound, follow-up) and menstrual cycle tracking for timing relative to the expected period. This is based on outcomes data/clinical truth.
Lay User Study: Comparison against results obtained by professional users testing aliquots of the same samples (both actual and spiked urine). This is a consensus or expert interpretation ground truth for comparing interpretational consistency.
Specificity Study (False Positives in Non-Pregnant Women): Quantitative ELISA hCG level test kit results and subsequent clinical confirmation for any elevated hCG or positive results. This combines a laboratory assay ground truth with clinical confirmation/outcomes data.

8. The sample size for the training set:

This document describes a 510(k) submission for a traditional in-vitro diagnostic test kit (lateral flow immunoassay) based on chemical reactions and visual interpretation. It is not an AI/ML-based device, and therefore, there is no "training set" in the context of machine learning. The development of such a device involves iterative R&D, chemical formulation, and design, but not data-driven algorithmic training.

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

As there is no AI/ML training set, this question is not applicable to the described device.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

December 22, 2017

True Diagnostics, Inc. c/o Jinjie Hu Biologics Consulting Group 1555 King Street, Suite 300 Alexandria, VA 22314

Re: K172257

Trade/Device Name: TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format) Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI, LCX Dated: November 7, 2017 Received: November 9, 2017

Dear Jinjie Hu:

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 Part

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801 and Part 809); medical device reporting of 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.

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 B. Kelm -S

for 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) K172257

Device Name

TrueDx™ hCG Early Result Pregnancy Test (Midstream Format) TrueDxTM hCG Early Result Pregnancy Test (Cassette Format)

Indications for Use (Describe)

Important note regarding negative result:

Some pregnant women will not be able to detect hCG in their urine 5 days before the expected period. If you test negative before your missed period, but think you may still be pregnant, you should test against a few days after you missed period.

Important note regarding positive results:

Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. If you test positive, but think you may not be pregnant, you should check with your doctor.

All results should be confirmed by your healthcare provider, especially when making decision about future medical care.

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

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

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Indications for Use

510(k) Number (if known) K172257

Device Name

VeriClear™ Early Result Pregnancy Test (Midstream Format) VeriClear™ Early Result Pregnancy Test (Cassette Format)

Indications for Use (Describe)

Important note regarding negative result:

Important note regarding positive results:

All results should be confirmed by your healthcare provider, especially when making decision about future medical care.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/4/Picture/1 description: The image shows the logo for True Diagnostics. The logo features a blue, stylized, four-petal design on the left. To the right of the design, the word "TRUE" is written in blue, and the word "DIAGNOSTICS" is written in gray. Below the words, the phrase "FOR POINT OF CARE ANSWERS" is written in a smaller, gray font.

K172257 510(k) Summary

This summary of safety and effectiveness information is being submitted in accordance with 21CFR807.92.

Date of Summary Prepared: December 20, 2017

Company Name and Address:

True Diagnostics, Inc. 2782 Loker Ave. West Carlsbad, CA 92010 Tel: (888) 571-8597

Contact Information: Jinjie Hu Ph.D. 1555 King Street Suite 300 Alexandria, VA 22314 Tel: 301-814-4985 Email: jhu@biologicsconsulting.com

A. 510(k) Number Under Review: K172257
B. Purpose for Submission: New Device
C. Measure: Human Chorionic Gonadotropin (hCG)

D. Type of Test Qualitative chromatographic immunoassay

E. Applicant:

True Diagnostics, Inc. U.S.A

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Image /page/5/Picture/1 description: The image shows the logo for True Diagnostics. The logo features a blue, stylized four-petal design on the left. To the right of the design, the word "TRUE" is in blue, and the word "DIAGNOSTICS" is in gray. Below the words, the phrase "FOR POINT OF CARE ANSWERS" is in a smaller font.

F. Proprietary and Established Names:

TrueDX™ hCG Early Result Pregnancy Test (Cassette Format) TrueDX 114 hCG Early Result Pregnancy Test (Midstream Format) VeriClear™ Early Result Pregnancy Test (Cassette Format) VeriClearTM Early Result Pregnancy Test (Midstream Format)

G. Regulatory Information:

1. Regulation section: 21 CFR § 862.1155 Human chorionic gonadotropin (hCG) test System
1. Classification: Class II
1. Product Code: Visual Pregnancy, hCG, Prescription JHI: LCX: hCG, Over the Counter
1. Panel: Chemistry (75)

H. Intended Use:

1. Intended use(s): See Indications for use below
1. Indication(s) for use:

TrueDX™ hCG Early Result Pregnancy Test (Cassette and Midstream format) is a rapid chromatographic immunoassay for qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.

Important note regarding negative result:

Important note regarding positive results:

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Image /page/6/Picture/1 description: The image is a logo for True Diagnostics. The logo features a blue abstract symbol on the left, followed by the words "TRUE DIAGNOSTICS" in blue and gray. Below the company name, the words "FOR POINT OF CARE ANSWERS" are written in a smaller font.

All results should be confirmed by your healthcare provider, especially when making decision about future medical care.

This product is intended for prescription use.

VeriClear™ Early Result Pregnancy Test (Cassette and Midstream format) is a rapid chromatographic immunoassay for qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.

Important note regarding negative result:

Important note regarding positive results:

All results should be confirmed by your healthcare provider, especially when making decision about future medical care.

This product is intended for over-the-counter use.

3. Special condition for use statement(s):

TrueDXTM hCG Early Result Pregnancy Test (Cassette and Midstream format) is intended for prescription use.

VeriClear™ Early Result Pregnancy Test (Cassette and Midstream format) is intended for over-the-counter use.

4. Special instrument Requirements:

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None

I. Device Description:

The VeriClear™ Early Result Pregnancy Test and TrueDX™ hCG Early Result Pregnancy Test are the same devices, except the device names and intended use population.

J. Substantial Equivalence Information:

1. Predicate device name(s):
  Church & Dwight Co., FIRST RESPONSE Early Result Pregnancy Test
1. Predicate K number(s):
  K123436
1. Comparison with predicate

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Image /page/8/Picture/1 description: The image is a logo for True Diagnostics. The logo features a blue, stylized four-petal design on the left. To the right of the design, the words "TRUE DIAGNOSTICS" are written in a sans-serif font, with "TRUE" in blue and "DIAGNOSTICS" in gray. Below the company name, the tagline "FOR POINT OF CARE ANSWERS" is written in a smaller, gray font.

Feature	Proposed DeviceK172257	Predicate DeviceK123436
Similarity
Intended Use	As an aid in early detection ofpregnancy, in some cases asearly as five (5) days beforethe expected period, i.e., asearly as six (6) days before theday of the missed period.	Same
Sample Matrix	Urine	Same
Test Principle	Lateral flow sandwichimmunochromatographicassay	Same
Limit of Detection	10 mIU/ml	Same
Traceability	WHO 4th InternationalStandard	Same
Time to result	3 minutes	Same
Differences
Target Users	TrueDX™ hCG Early ResultPregnancy Test (Cassette andMidstream format) is intendedfor prescription use.VeriClear™ Early ResultPregnancy Test (Cassette andMidstream format) is intendedfor over the counter use.	Over-the-Counter Use only
Shelf life	24-month shelf life whenstored in a dry place between39 to 86°F	24-month shelf life when storedin a dry place below 86°F
hCG isoforms detected	Intact hCGHyperglycosylated hCGhCG ß -subunit	Intact hCGHyperglycosylated hCGhCG ß -subunithCG ß -core fragment

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Image /page/9/Picture/1 description: The image is a logo for True Diagnostics. The logo features a blue, stylized four-petal design on the left. To the right of the design is the text "TRUE DIAGNOSTICS" in a sans-serif font. Below that text is the phrase "FOR POINT OF CARE ANSWERS" in a smaller font.

K. Standard/Guidance Document referenced (if applicable):

FDA Guidance document: Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s

FDA Guidance document: Review Criteria for Assessment of Professional Use Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs)

L. Test Principle:

TrueDX™ hCG Early Result Pregnancy Test and VeriClear™ Early Result Pregnancy Test are sandwich immunoassays employing mouse monoclonal antibodies specific for hCG, which are immobilized on the membrane as test line, with Goat anti-mouse IgG immobilized as control line. After the urine specimen applied to the device, the analyte hCG present in the specimen will react with the mouse anti hCG monoclonal antibodycolloidal gold conjugate. The complex moves via toward to the testing and control zones. Two lines (both Test and Control) showed on test window 3 minutes after the urine application if hCG is present indicating pregnancy. If Test line is absent and only Control line showed color on the test window after 3 minutes indicating the test works but no hCG present in the specimen. In case the Control line does not show any color 3 minutes after application of the specimen, the test is invalid and the specimen should be retest.

M. Performance Characteristics (if/when applicable):

VeriClear™ Early Result Pregnancy Test and TrueDX™ hCG Early Result Pregnancy Test are identical. Therefore, only one set of representative performance data is presented below.

1. Analytical performance:

a. Precision/Reproducibility:

A precision study was performed using standard samples spiked with hCG traceable to the 4th WHO international standard with hCG concentrations of 0, 3.0 5.0, 8.5, 10, 25, 50, and 100 mIU/ml. Each sample were tested for 10 replicates each day, with three lots of devices (for both formats) by 5 operators, over 5 days. A total of 250 replicates (10 replicates/run x 5 operators x 5 days) per lot device for each sample were obtained.

Precision Study for three lots Devices-Midstream Format

hCGlevel(mIU/ml)	Lot 1	Lot 2	Lot3	% Positive
0	0/250	0/250	0/250	0 %

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Image /page/10/Picture/0 description: The image is a logo for True Diagnostics. The logo features a blue, stylized four-petal design on the left. To the right of the design, the words "TRUE DIAGNOSTICS" are written in a sans-serif font, with "TRUE" in blue and "DIAGNOSTICS" in gray. Below the company name, the words "FOR POINT OF CARE ANSWERS" are written in a smaller font size.

3	0/250	0/250	0/250	0 %
5	0/250	0/250	0/250	0 %
8.5	135/250	139/250	130/250	53.8 %
10	250/250	250/250	250/250	100%
25	250/250	250/250	250/250	100%
50	250/250	250/250	250/250	100%
100	250/250	250/250	250/250	100%

Precision Study for three lots devices -Cassette Format

hCGlevel(mIU/ml)	Lot 1	Lot 2	Lot3	% Positive
0	0/250	0/250	0/250	0 %
3	0/250	0/250	0/250	0 %
5	0/250	0/250	0/250	0 %
8.5	115/250	110/250	135/250	48 %
10	250/250	250/250	250/250	100%
25	250/250	250/250	250/250	100%
50	250/250	250/250	250/250	100%
100	250/250	250/250	250/250	100%

Precision Study for five Operators -Midstream

hCG level(mIU/ml)	Operator1	Operator2	Operator3	Operator4	Operator5	% Positive
0	0/150	0/150	0/150	0/150	0/150	0 %
3	0/150	0/150	0/150	0/150	0/150	0 %
5	0/150	0/150	0/150	0/150	0/150	0 %
8.5	84/150	82/150	79/150	74/150	85/150	53.8%
10	150/150	150/150	150/150	150/150	150/150	100%
25	150/150	150/150	150/150	150/150	150/150	100%
50	150/150	150/150	150/150	150/150	150/150	100%
100	150/150	150/150	150/150	150/150	150/150	100%

Precision Study for five Operators -Cassette

hCG level(mIU/ml)	Operator1	Operator2	Operator3	Operator4	Operator5	% Positive
-----------------------	---------------	---------------	---------------	---------------	---------------	------------

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0	0/150	0/150	0/150	0/150	0/150	0 %
3	0/150	0/150	0/150	0/150	0/150	0 %
5	0/150	0/150	0/150	0/150	0/150	0 %
8.5	69/150	69/150	71/150	77/150	74/150	48%
10	150/150	150/150	150/150	150/150	150/150	100%
25	150/150	150/150	150/150	150/150	150/150	100%
50	150/150	150/150	150/150	150/150	150/150	100%
100	150/150	150/150	150/150	150/150	150/150	100%

Within Lot Reproducibility

The repeatability and reproducibility of the TrueDX™ hCG Early Result Pregnancy test (Midstream and cassette format) was challenged over one day with one lot of test device by one operator. This consists of (20) replicates for each level of standard of 0, 3.0 5.0, 8.5, 10, 25, 50, and 100 mIU/ml.

The data has demonstrated excellent within lot repeatability of TrueDX™ hCG Early Result Pregnancy Test. The Results are summarized in the following tables:

Within-Lot Reproducibility

hCG level(mIU/ml)	Total # ofTest	TrueDXTM hCG Early ResultPregnancy Test DeviceLot#: 0500116(Simulate Stream Method)
		Observed	% of Positive
		Negative	Positive
0	20	20	0	100
3.0	20	20	0	100
5.0	20	20	0	100
8.5	20	9	11	55
10.0	20	0	20	100
25.0	20	0	20	100
50.0	20	0	20	100
100.0	20	0	20	100

hCG level(mIU/ml)	Total # ofTest	TrueDX TM hCG Early ResultPregnancy Test DeviceLot#: 0500116(Midstream Dip Method)
		Observed	% of Positive

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		Negative	Positive
0	20	20	0	100
3.0	20	20	0	100
5.0	20	20	0	100
8.5	20	9	11	55
10.0	20	0	20	100
25.0	20	0	20	100
50.0	20	0	20	100
100.0	20	0	20	100

hCG level(mIU/ml)	Total # ofTest	TrueDX TM hCG Early ResultPregnancy Test Device(Cassette)Lot #:0501016
		Observed		% of Positive
		Negative	Positive
0	20	20	0	100
3.0	20	20	0	100
5.0	20	20	0	100
8.5	20	12	8	55
10.0	20	0	20	100
25.0	20	0	20	100
50.0	20	0	20	100
100.0	20	0	20	100

b. Linearity/assay reportable range: Not applicable.
c. Traceability, Stability, Expected values (controls, calibrators, or method): Traceability: The tests are calibrated against the WHO 4thInternational Standards for hCG.
d. Shelf Life

The stability testing protocol and acceptance criteria used to support the shelf life were reviewed and found to be acceptable. The sponsor claims a 24 month shelf life for all two formats when stored in the sealed foil pouch at 39-86°F (4-30°C).

Detection limits (sensitivity): e.

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An analytical sensitivity study was performed using negative human urine sample spiked with hCG traceable to the WHO 4th IS for hCG to obtain concentration of 0, 3.0, 5.0, 7.5, 8.5, 9.0,10, 12.5, 15, and 25 mIU/ml hCG. The samples were measured in 15 replicates, using 3 different lots of each test format. The tests were performed by 3 different operators for 3 consecutive days. A different set of operators tested each format of the device.

The obtained results are summarized in the following tables.

hCGConcentration(mIU/ml)	Lot 1	Lot 2	Lot 3	% Positive
0	0+/15	0+/15	0+/15	0%
3	0+/15	0+/15	0+/15	0%
5	0+/15	0+/15	0+/15	0%
7.5	3+/15	2+/15	3+/15	17.7%
8.5	8+/15	9+/15	9+/15	57.7%
9.0	14+/15	14+/15	14+/15	93.3%
10	15+/15	15+/15	15+/15	100%
12.5	15+/15	15+/15	15+/15	100%
15	15+/15	15+/15	15+/15	100%
25	15+/15	15+/15	15+/15	100%

Midstream Format

Cassette Format

hCGConcentration(mIU/ml)	Lot 1	Lot 2	Lot 3	% Positive
0	0+/15	0+/15	0+/15	0 %
3	0/+15	0/+15	0/+15	0%
5	0+/15	0+/15	0+/15	0 %
7.5	3+/15	2+/15	4+/15	20%
8.5	8+/15	9+/15	8+/15	55%
9.0	13+/15	14+/15	13+/15	88.8%
10	15+/15	15+/15	15+/15	100 %
12.5	15+/15	15+/15	15+/15	100 %
15	15+/15	15+/15	15+/15	100 %
25	15+/15	15+/15	15+/15	100 %

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The results demonstrated that the analytical sensitivity of the new device (the lowest concentration that yields 100 % positive results) is 10 mIU/ml.

Analytical specificity f.

Structure non-related compounds:

To evaluate potential interference from certain exogenous compounds, each interferent was made at 100 X concentration bulk and spiked into negative urine and positive urine samples (containing 10 mIU /ml hCG). Each spiked urine sample was mixed and to make sure a homogeneous solution before testing. Each sample was tested using 2 different lots of the testing kit. The interference studies demonstrated that there was no interference for the highest concentrations of substance tested for each of the reagent lots and for each concentration of hCG tested negative and 10 mIU/ml hCG).

Analytical Specificity Study

Analytical specificity was studied among potential interfering substances including various prescription and OTC drugs. The name of the substances and the concentration tested listed in the table below. All the substances were tested without hCG or with hCG at 10mIU/ml. All samples were tested in replicates of 5 for each format. No interfering impact was observed on the performance of the candidate test.

Substance tested	Highest Concentration tested that demonstrated no interference Concentration
Acetaminophen	20 mg/dl
Acetylsalicylic acid	20 mg/dl
Human serum Albumin	2000 mg/dl
Ampicillin	20 mg/dl
Ascorbic acid	20 mg/dl
Atropine	20 mg/dl
Caffeine	20 mg/dl
Cortisol	200 ng/dl
EDTA	80 mg/dL
Phenylpropanolamine	20 mg/dL
Ephedrine	20 mg/dL
Gentisic acid	20 mg/dl
Glucose	2000 mg/dl

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Tetracycline	20 mg/dl
Uric acid	10 mg/dl
Bilirubin	20 mg/dL
Ethanol	0.1 %
Salicylic Acid	20 mg/dL

Cross reactivity of structure similar compounds:

Negative and positive urine contain 10 mIU/ml hCG were spiked with various concentrations of the following potential cross reactants: hLH, hFSH, and hTSH. The samples were tested by two operators with two lots of the test kit for each format. The result from spiked samples demonstrated no cross reactivity at following concentrations:

Cross Reactivity Study

TrueDX TM hCG Early Result Pregnancy Test
(Midstream format)
Substance	Concentrations
hLH	1000 mIU/ml
hFSH	1000 mIU/ml
hTSH	1000 µIU/ml

TrueDX TM hCG Early Result Pregnancy Test
(Cassette Format)
Substance	Concentrations
hLH	1000 mIU/ml
hFSH	1000 mIU/ml
hTSH	1000 $ μ $ IU/ml

Cross reactivity with hyper-glycosylated hCG

A study was performed to evaluate the reactivity of hyper-glycosylated hCG on the device. The h. hCG was made at high concentration bulk and spiked into negative urine. Each spike urine sample (1.47 µg/L, 0.147 µg/L, 0.0147 µg/L and 0.00147 µg/L) was mixed for at least 5 minutes to ensure a homogeneous solution before testing. Each sample was tested using 5 replicates of 3 different lots of each format testing kit. The studies demonstrated that All replicates tested with H. hCG standards at above 0.0147

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ug/L (5.8 mIU/ml) yielded positive results with both midstream and cassette format test device.

Effect of urine pH

A study was performed to evaluate the effect of pH on the device. Negative urine and positive urine (10 mIU/ml) were adjusted to have pH values of 4.0, 5.0, 6.0,7.0, 8.0, and 9.0. both negative and positive hCG samples with the different pH levels were tested on each format of device. The positive and negative hCG results were not affected by urine pH levels between the ranges of 4.0 and 9.0.

Effect of urine specific gravity:

A study was performed to evaluate the effect of urine specific gravity on the device. The device was challenged with negative urine and positive urine (containing 10 mIU/ml) with specific gravities of 1.000, 1.005,1.010,1.015,1.020, 1.025,1.030,and 1.035. The positive and negative hCG results were not affected by urine specific gravity concentrations between 1.00 and 1.035

High dose hook effect study:

Negative urine samples were spiked with hCG at concentrations of ranging from 20,000 mIU/ml to 450,000 mIU/ml. Three lots of the device for each format were tested by 2 different operators. The results demonstrated that no hook effect was observed at hCG concentrations up to 450,000 mIU/ml.

Effect of hCG B-core fragment:

Interference testing was performed to evaluate whether high levels of beta core fragment interfere with the test kit. Negative urine hCG (0 mIU/ml and 5 mIU/ml) and positive urine samples (containing 10 mIU/ml,25 mIU/ml and 20,000 mIU/ml) were spiked with hCG beta core fragment at concentrations of 50,400, 102,000 and 408,000 p mole/L. Concentration of hCG beta core fragment up to 408,000 p mole/L vielded correct results.

Assay cutoff g.
See detection limit section.

The results demonstrated that the analytical sensitivity of the new device (the lowest concentration that yields 100 % of positive results) is 10 mIU/ml.

Comparison studies: 2.

Method comparison with predicate device: a.

Urine samples were collected from 166 women at physician offices for pregnancy testing. Of the 166 women. 65 of them were suspected to be pregnant. Patient sample were randomly collected at various time throughout the day. Age of these women

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Image /page/17/Picture/1 description: The image is a logo for True Diagnostics. The logo features a blue, stylized, four-petal design on the left. To the right of the design is the text "TRUE DIAGNOSTICS" in a sans-serif font, with "TRUE" in blue and "DIAGNOSTICS" in gray. Below the company name is the text "FOR POINT OF CARE ANSWERS" in a smaller font size, also in gray.

ranged from 19 to 41 years. Samples were masked and randomized by people who labeled the sample but did not participate in the testing. A total of 166 samples were tested for each format (Midstream and Cassette). All samples were tested by two different health care professionals. Each person tested two different lots of each format device at same time. For the midstream format, one lot of test device were tested by the simulate stream method, another lot of test device were tested by dip method. The results are summarized in table below.

		Predicate Device		Total
		hCG +	hCG-
CandidateDevice	hCG +	65	0	65
	hCG-	0	101	101
Total		65	101	166

b. Matrix comparison: Not Applicable

3. Clinical Studies:

Clinical Sensitivity: a. Not Applicable
b. Clinical Specificity: Not Applicable
c. Other clinical supportive data (when a and b are not applicable):

Detection of hCG in Early Pregnancy Clinical Samples

A total of 616 urine samples urine were collected from 56 different women (25 - 45 years old) who planned to become pregnant. These women were followed throughout their conception cycles with urine collected from day -9 to day +1 of their expected period. The Candidate device (both formats) detected hCG in 71% of samples from five days before the expected menstrual period and 100% of samples from one day before the expected menstrual period.

The early pregnancy detection results are summarized below:

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Day in cyclerelative to EMP	Midstream Format	Cassette Format	Overall PregnancyDetection Rate (%)
-9 days	0%	0%	0%
-8 days	0%	0%	0%
-7 days	12.5%	12.5%	12.5%
-6 days	41%	41%	41%
-5 days	71%	71%	71%
-4 days	94%	94%	94%
-3 days	98%	98%	98%
-2 days	98%	98%	98%
-1 days	100%	100%	100%
0 days	100%	100%	100%
+1 days	100%	100%	100%

Lay user study

A lay user study was performed at intended use sites with a total of 218 females with diverse educational and professional backgrounds and ages ranging from 18 to 63 years. 110 lay users tested with midstream devices and 108 lay users tested with cassette format devices. Lay users were only provided the package insert prior to perform the study.

Lay user results compare to professional user results are listed below.

Pregnancy Result	Lay user/professional
	Midstream	Midstream-Dip	Cassette
Pregnant	9/9	9/9	6/6
Non-pregnant	101/101	101/101	102/102
Total	110	110	108

Besides testing their own urine samples, the same lay users also tested spiked urine

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samples around the cut-off level at 3.0 mIU, 7.0 mIU/ml, 8.5 mIU/ml and 10 mIU/ml hCG concentrations. A total of 53 samples at each hCG level were tested on Midstream. 57 samples were tested on Midstream using dip method and 110 samples were tested on Cassette format. One lot of each of the two test formats were used in the study. An aliquot of each of the urine samples was also tested by a professional using the candidate device. The results are summarized below.

hCGmIU/ml	Lay user/professional		Lay user/professional		Lay user/professional
	Midstream		Midstream-Dipmethod		Cassette
	Numberssubject +	PercentageAgreement	Numberssubject +	PercentageAgreement	Numberssubject +	PercentageAgreement
3	0, 0	100%	0, 0	100%	0, 0	100%
7.0	8, 9	98%	20, 18	96%	23, 26	97%
8.5	30, 32	96%	36, 38	96%	81, 84	97%
10	53, 53	100%	57, 57	100%	110, 110	100%

All the lay users participated the study were given a questionnaire to rate how well they understand the instruction in the package insert. A Flesch-kincaid reading analysis was performed to determine that the OTC package insert content is appropriate for a reading Grade level of 7.9. The result of the questionnaire reflect that the consumers found the test easy to use and they did not have trouble understanding the labeling or interpreting results.

Specificity study to determine false-positive result rate

A study was performed to determine the incidence of positive test results from True Diagnostic Early Result Pregnancy Test Device among non pregnant women in three age groups, 18 - 41 years of age (Pre-menopausal), 42-55 years of age (peri-menopausal) and >55 year of age (post- menopausal). A total of 320 subject provided urine samples with 100 from the pre-menopausal subjects, 111 from the peri-menopausal subjects, and 109 in the post-menopausal subjects. Three lots of each test format of the candidate devices were used for this study. ELISA quantitative analyzed hCG level test kit was used in the study. Subject s with a positive test result on the new device or hCG threshold levels >5.00 MIU/ml on ELISA test procedure were referred to clinical confirmation of positive. The results are summarized in table below:

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Age Group	UrineN	Positiveresult
Pre- Menopausal urines(Age: 18 to 41)	100	0
Peri-menopausal urines(Age: 42 to 55)	111	0
Post-menopausal urines(Age >55)	109	0

4. Clinical Cut-off

Not applicable

Expected value/ Reference Range: న్.

Not applicable

N. Propose Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

0. 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.