(217 days)
Not Found
No
The device description and performance studies focus on a lateral flow chromatographic immunoassay, which is a traditional biochemical method for detecting hCG. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI/ML.
No
Explanation: This device is an in vitro diagnostic (IVD) device used for determining pregnancy by detecting hCG levels, not for treating any condition or disease.
Yes
The "Intended Use / Indications for Use" section states that the device is intended "to aid in the determination of pregnancy," which is a diagnostic purpose. The "Device Description" also explicitly refers to it as an "in vitro diagnostic device."
No
The device description clearly outlines a physical, in vitro diagnostic device that uses a lateral flow chromatographic immunoassay to detect hCG in urine. This involves physical components like an absorbent end, membrane, and antibodies, which are not software-only elements.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for non-professional, over-the-counter use for the qualitative identification of the elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy." This describes a test performed on a sample taken from the human body (urine) to provide information about a physiological state (pregnancy).
- Device Description: The "Device Description" further clarifies that it is an "in vitro diagnostic device for the qualitative identification of the elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy." It also describes the biological and chemical processes involved in the test, which are characteristic of in vitro diagnostics.
- Performance Studies: The "Summary of Performance Studies" details various tests conducted to evaluate the device's performance using biological samples (urine), including precision, cross-reactivity, interfering substances, limit of detection, and clinical performance studies comparing it to a predicate device and standard of care. These types of studies are standard for IVD devices.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K974159; OSOM hCG Urine Test) is a strong indicator that this device is being compared to another legally marketed IVD device, which is a common regulatory pathway for new IVDs.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Lia Pregnancy Test is intended for non-professional, over-the-counter use for the qualitative identification of the elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy.
Product codes
LCX
Device Description
The Lia Pregnancy Test is an in vitro diagnostic device for the qualitative identification of the elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy.
The method employs a unique combination of monoclonal-dye conjugate and polyclonal-solid phase antibodies to selectively identify hCG in the test samples. The sensitivity of the test has been adjusted to 22mlU/mL. The Lia Pregnancy Test is a lateral flow chromatographic immunoassay. When a mid-stream urine sample is applied to the absorbent end, the sample enters the device by capillary action and mixes with the antibody-dye conjugate (mouse anti-beta hCG monoclonal antibody), flowing across the pre-coated (Goat anti-alpha hCG polyclonal antibody) membrane. During the test, hCG in the urine specimen reacts with the dye conjugate and forms a complex. The complex migrates along the cellulose strip to the α-hCG antibody line (T), and remains captured in the T line. As a result, a red colored band develops in the T line, indicating a positive result. If there is no hCG in the urine, there is no red band in the test zone, indicating a negative result. The control line develops in the Control (C) zone regardless of the result.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
18 – 49 years
Intended User / Care Setting
non-professional, over-the-counter use / Home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
For the Lia Clinical Study, a total of N=153 women, attending four different women's health clinics, self-performed the Lia Pregnancy Test according to Package Insert instructions. Approximately half of the subjects were suspected to be pregnant. Lay-users collected a mid-stream sample on the Lia Pregnancy Test and a small aliquot in a specimen cup. The later sample was tested with the predicate device in clinical lab by a professional. The lay-user recorded their interpretation of the Lia Pregnancy Test results and then a clinical staff member examined and reported their interpretation of Lia Pregnancy Test results. Samples were randomly collected at various times throughout the day. Ages of these women ranged from 18 to 49 years.
In an additional lay user study, 15 women performed simulated mid-stream tests with samples provided by Lia at defined hCG concentrations, close to the cutoff. In this study, 15 lay-users tested three different samples (2, 33, and 100mlU/mL) on three different lots of the Lia Pregnancy Test. Users were "blinded" as to sample status, and recorded their interpretation of the results.
Summary of Performance Studies
Study Type: Clinical Performance, Non-Clinical Performance (Precision/Reproducibility, Cross-reactivity, Interfering Substances, Limit of Detection, Stability/Shelf Life, Effects of Urine pH, Effects of Urine Specific Gravity, High Dose Hook Effect, Beta hCG Core Fragment Reactivity testing).
Sample Size: 174 lay-user consumers (usability studies), N=153 women (clinical study), 15 lay-users (additional lay user study).
Key Results:
- Precision/Reproducibility: The Lia Pregnancy Test exhibited reproducibility of results (sero-negative and hCG sero-positive members) across a multi-kit lot, multi-operator and multiday study.
- Cross-reactivity: Neither hLH, hFSH nor hTSH affect the correct call of sero-negative and hCG sero-positive urine samples in the Lia Pregnancy Test.
- Interfering Substances: The presence of a wide array of potentially interfering substances which could be found in human urine failed to affect the correct call rates of sero-negative and hCG seropositive samples on the Lia Pregnancy Test.
- Limit of Detection: The Lia Pregnancy Test exhibited 100% detection of WHO #5 hCG-spiked samples at 22 and 25 mlU/ml and detected 50% of hCG-spiked samples with concentrations at 14 mIU/ml.
- Stability/Shelf Life: Data supports an 18-month shelf life claim.
- Effects of Urine pH: Performance of the Lia Pregnancy Test is not affected by pH of the urine sample.
- Effects of Urine Specific Gravity: Performance of the Lia Pregnancy Test was not affected by the specific gravity of the urine samples, either above or below, the normal range.
- High Dose Hook Effect: Results show the Lia Pregnancy Test does not exhibit prozone activity from 25 to 500,000 mIU/ml concentrations of hCG.
- Beta hCG Core Fragment Reactivity testing: The Lia Pregnancy Test detects ßhCGcf at concentrations >1000 pmol/L and detects low- and high-titer intact hCG even when ßhCGcf is present.
- Clinical Performance: The conformity between the user interpretation of the Lia Pregnancy Test and the staff interpretation of the Lia Pregnancy Test is 98.7%. The conformity between the staff interpretation of the Lia Pregnancy and the standard of care is 100%. Data analysis shows that lay-users can successfully interpret the results, and that the test results were 100% concordant with the standard of care. In the post test questionnaire users report that the test is easy to use and the instructions are easy to understand. 98% of lay-users said that the printed instructions were clear and usable. 91% of participants were confident that they had performed the test correctly. 98% said it was easy to use the test. In the additional lay user study, 100% of users correctly identified positive and negative results.
Key Metrics
- Conformity between user interpretation and staff interpretation: 98.7%
- Conformity between staff interpretation and standard of care: 100%
- Test results concordance with standard of care: 100%
- Lay-user confidence in performing test correctly: 91%
- Lay-user perception of ease of use: 98%
- Lay-user perception of clear and usable instructions: 98%
Predicate Device(s)
K974159 OSOM hCG Urine Test
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The FDA text is in blue, with "FDA" in a square and the rest of the text in a rectangular shape.
July 27, 2018
LIA Diagnostics Anna Couturier Official Correspondent 1015 Chestnut St Suite 1401 Philadelphia, Pennsylvania 19107
Re: K171136
Trade/Device Name: LIA Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: October 23, 2017 Received: October 23, 2017
Dear Anna Couturier:
This letter corrects our substantially equivalent letter of November 20, 2017.
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
1
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 comprehensive regulatory information about medical devices and radiation-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,
Courtney H. Lias -S
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K171136
Device Name
Lia Pregnancy Test
Indications for Use (Describe)
Lia Pregnancy Test is intended for non-professional, over-the-counter use for the qualitative identification of the elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy.
Type of Use (Select one or both, as applicable)
| Exemption Under Part 503.44(a) Criteria - Domestic Septage | |
|---|---|
| ✓ | One-Time Occurrence Under Part 503.44(b) Criteria - Site Specific |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
LIA Diagnostics 1015 Chestnut Street Suite 1401 Philadelphia, PA 19107
510(k) SUMMARY For K171136 Lia Pregnancy Test
Submitter Information:
LIA Diagnostics, Inc. 1015 Chestnut Street Suite 1401 Philadelphia, PA 19107
Contact Person: Anna Couturier Telephone Number: 717-799-7795
Date Prepared: November 17, 2017
Device Name:
| Proprietary Name: | |
|---|---|
| Classification Name: | Kit, test, pregnancy, hCG, over-the-counter |
| Common Name: | Lia Pregnancy Test |
| CFR Number: | 21 CFR 872.1155 |
| Device Class: | II |
| Product Code: | LCX |
Predicate Device:
| Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| OSOM hCG Urine Test | k9741 59 Sekisui Diagnostics |
Table 1. Predicate device information
Description of Device:
The Lia Pregnancy Test is an in vitro diagnostic device for the qualitative identification of the elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy.
The method employs a unique combination of monoclonal-dye conjugate and polyclonal-solid phase antibodies to selectively identify hCG in the test samples. The sensitivity of the test has been adjusted to 22mlU/mL. The Lia Pregnancy
4
Test is a lateral flow chromatographic immunoassay. When a mid-stream urine sample is applied to the absorbent end, the sample enters the device by capillary action and mixes with the antibody-dye coniugate (mouse anti-beta hCG monoclonal antibody), flowing across the pre-coated (Goat anti-alpha hCG polyclonal antibody) membrane. During the test, hCG in the urine specimen reacts with the dye conjugate and forms a complex. The complex migrates along the cellulose strip to the α-hCG antibody line (T), and remains captured in the T line. As a result, a red colored band develops in the T line, indicating a positive result. If there is no hCG in the urine, there is no red band in the test zone, indicating a negative result. The control line develops in the Control (C) zone regardless of the result.
Indications for Use:
Lia Pregnancy Test is intended for non-professional, over-the-counter use for the qualitative identification of the elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy.
The Lia Pregnancy Test is intended for Over-the-Counter use.
Identification of Risk Analysis Method
Risk analysis was performed on the Lia Pregnancy Test utilizing an FMEA process based on ISO 14971:2012. The results of the risk analysis performed on the Lia Pregnancy Test concluded that all device design controls and process controls will be able to mitiqate known potential failures and effects. In addition, usability and performance testing were performed to mitigate other potential risks.
Substantial Equivalence:
| ELEMENT | PROPOSED DEVICE:
Lia Pregnancy Test | PREDICATE DEVICE:
OSOM hCG Urine Test | DIFFERENCES
WITH
PREDICATE
DEVICE |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| 510(k) | K171136 | K974159 | |
| Indications for
Use | Lia Pregnancy Test is
indicated for use intended
for non-professional, over-
the-counter use for the
qualitative identification of
the elevated levels of
human Chorionic
Gonadotropin (hCG) in
urine to aid in the
determination of
pregnancy. | For the qualitative
determination of human
chorionic gonadotropin
(hCG) in urine for the
early detection of
pregnancy. | Predicate
intended for POC
(point-of-care). |
5
| Specimen | Urine | Urine | Same |
|---|---|---|---|
| Methodology | Immunochromatographic | ||
| Assay | Immunochromatographic | ||
| Assay | Same | ||
| Time to Result | 5 minutes | 5 minutes | Same |
| Analytical | |||
| Sensitivity | 25mIU/mL | 25mIU/mL | Same |
| Results | Qualitative | Qualitative | Same |
| Material | |||
| Composition | • Assay substrate – One | ||
| contiguous cellulose web | |||
| for sample pad, conjugate | |||
| pad, test strip and | |||
| absorbent wick | |||
| • Antibody – | |||
| Mouse monoclonal, goat | |||
| polyclonal | • Cover - plastic | ||
| • Assay substrate – | |||
| Cellulose sample | |||
| collection pad, glass fiber | |||
| conjugate pad, | |||
| nitrocellulose test strip, | |||
| cellulose absorbent wick | |||
| • Antibody – | |||
| mouse monoclonal, rabbit | |||
| polyclonal | Membrane | ||
| material of Lia is | |||
| cellulose, not | |||
| nitrocellulose, like | |||
| the membrane of | |||
| the predicate. | |||
| Both substrates | |||
| are inert and do | |||
| not affect the test | |||
| results. | |||
| Material | |||
| Compatibility | Biocompatibility meets | ||
| requirements | Biocompatibility meets | ||
| requirements | None | ||
| Target | |||
| population | Traditional and normal | ||
| females for determination | |||
| of pregnancy | Traditional and normal | ||
| females for | |||
| determination of | |||
| pregnancy | Same | ||
| Device | |||
| design | Handheld, mid-stream | ||
| design. Lateral flow test | |||
| strip housed inside a | |||
| hydrophobic cellulose | |||
| housing with a viewing | |||
| window for results | |||
| interpretation. | Lateral flow dipstick test | ||
| strip | |||
| Performance | Use friendly interface, | ||
| easy to operate | Use friendly interface, | ||
| easy to operate | |||
| Sterility | Device provided non- | ||
| sterile | Device provided non- | ||
| sterile | |||
| Chemical | |||
| Safety | There are no hazardous | ||
| chemicals contained | |||
| within this kit at | There are no hazardous | ||
| chemicals contained | |||
| within this kit at | |||
| concentrations that are | |||
| considered hazardous to | |||
| personal health and/or the | |||
| environment. | concentrations that are | ||
| considered hazardous to | |||
| personal health and/or | |||
| the environment. | |||
| Compatibility | |||
| with | |||
| environment | |||
| and other | |||
| devices | The system is used inside | ||
| buildings. Interaction with | |||
| other devices is not | |||
| performed | The system is used | ||
| inside buildings. | |||
| Interaction with other | |||
| devices is not performed | |||
| Used at: | Home | Point of care | |
| Weight | 2.125g | .29 g | |
| Dimensions, | |||
| housing (cm.) | |||
| HxWxL | .38 x 5.5 x 15.5 | N/A | Predicate is a |
| test strip only | |||
| Dimensions, | |||
| test strip (cm. | |||
| HxWxL) | .035 x 3.7 x 17.5 | 10 x .4 x .1 | |
| Operating | |||
| temperature | +59°F to +93°F (+15°C to | ||
| +34°C) | +59°F to +86°F (+15°C | ||
| to +30°C) | |||
| Humidity | Operating, 20-76% | Operating, 15% to 75% | |
| Storage | |||
| temperature | 59F to 86F (1 5C to | ||
| 30C),in foil pouch | 59F to 86F (1 5C to | ||
| 30C), | |||
| Technology | |||
| Principle | dyed lateral-flow | ||
| immunoassay | dyed latex-based lateral- | ||
| flow immunoassay | |||
| Format | Cassette (non-plastic) | Dipstick | |
| Results | Qualitative | Qualitative | |
| Results | |||
| Interpretation | Visual | Visual | |
| Specimen | |||
| Type | Human urine | Human urine | |
| Specimen | |||
| Application | Mid-stream | Dipstick | |
| Cut-off Value | 25 mlU/ml | 25 mIU/ml | |
| Traceability | WHO International | ||
| Standard #5 | WHO International | ||
| Standard #3 | |||
| Quality | |||
| Control | Built-in, internal control | Built-in, internal control |
6
Table 2. Substantial equivalence
7
| Differences | |||
|---|---|---|---|
| Lia Pregnancy Test | Predicate Device | ||
| Test Format | Mid-stream format | Dipstick format | |
| Test strip | |||
| composition | One contiguous piece of | ||
| cellulose | Cellulose sample | ||
| collection pad, glass | |||
| fiber conjugate pad, | |||
| nitrocellulose test strip | |||
| Used at | Home | Point-of-Care |
Table 3. Differences between the Lia Pregnancy Test and legally marketed predicate
Minor differences exist between the Lia Pregnancy Test and the predicate device. The only differences are in the housing material and membrane of the test strip, neither of which affect the immunochromatographic results. These minor differences do not impact substantial equivalence of the Lia Pregnancy Test.
The Lia Pregnancy Test, and the predicate device. OSOM hCG Urine Test (K9741 59) use the same chemistry with essentially the same test design.
Non-Clinical Performance Data:
Because the proposed device, Lia Pregnancy Test, and the predicate device, OSOM hCG Urine Test (K9741 59) use similar materials with essentially the same test design, new biocompatibility testing or clinical testing was not required for the device to support substantial equivalence
Performance testing focused on verification of performance, and safety of the Lia Pregnancy Test. Below is a list of the standards to which testing was performed:
-
Precision/Reproducibility
- o To determine the reproducibility of the Lia Pregnancy Test using a 12-member hCG-spiked urine panel tested by multiple operators over multiple, non-consecutive days. The Lia Pregnancy Test exhibited reproducibility of results (sero-negative and hCG seropositive members) across a multi-kit lot, multi-operator and multiday study.
-
Cross-reactivity
- o To determine if the Lia Pregnancy Test was affected (i.e. crossreacted) by a relevant challenge dose of closely-related human lutieinzing hormone (hLH), human follicle stimulating hormone (hFSH) or human thyroid stimulating hormone (hTSH). Neither hLH, hFSH nor hTSH affect the correct call of sero-negative and hCG sero-positive urine samples in the Lia Pregnancy Test.
8
-
Interfering Substances
- o To determine if the Lia Pregnancy Test was affected by potentially interfering substances which may be found in human urine. The study assessed interference on both sero-negative and hCG seropositive samples. The presence of a wide array of potentially interfering substances which could be found in human urine failed to affect the correct call rates of sero-negative and hCG seropositive samples on the Lia Pregnancy Test.
-
Limit of Detection
- To determine the limit of detection (LoD) of the Lia Pregnancy Test using WHO #5 reference material. The Lia Pregnancy Test exhibited 100% detection of WHO #5 hCG-spiked samples at 22 and 25 mlU/ml and detected 50% of hCG-spiked samples with concentrations at 14 mIU/ml
-
Stability/Shelf Life
- o To investigate the Lia Pregnancy Test device's stability, the product was stored at ambient (anticipated end-user storage conditions) and thermal-stress conditions (37 °C and 50 °C) and tested against a panel of pedigreed urine samples. Data supports an 18-month shelf life claim
-
Effects of Urine pH
- To determine if the performance of the Lia Pregnancy Test was affected by the pH of urine samples. Performance of the Lia Pregnancy Test is not affected by pH of the urine sample.
-
Effects of Urine Specific Gravity
- o To determine if the performance of the Lia Pregnancy Test was affected by the specificity gravity of urine samples. The normal range for specific gravity of urine is 1 .003 to 1 .036. In this study, performance of the Lia Pregnancy Test was not affected by the specific gravity of the urine samples, either above or below, the normal range
-
High Dose Hook Effect (aka prozone)
- To determine if the Lia Pregnancy Test exhibits evidence of o prozone (aka "hook effect") behavior when challenged with a high concentration of analyte (hCG). In immunoassay tests which have prozone issues, false negative results could be reported despite the analyte being present in the sample. Results show the Lia Preqnancy Test does not exhibit prozone activity from 25 to 500,000 mIU/ml concentrations of hCG.
-
Beta hCG Core Fraqment Reactivity testing
- o To determine how the Lia Pregnancy Test how was affected by the beta-core fragment of hCG, a hCG-like molecule which may be present at high concentrations during pregnancy. The Lia Pregnancy Test detects ßhCGcf at concentrations >1000 pmol/L and detects low- and high-titer intact hCG even when ßhCGcf is present.
9
Along with the above tests, Stability of results, shipping stability, and environmental factors testing were also conducted and demonstrated compliance to specifications.
The results of these performance tests support the substantial equivalence of the proposed device, Lia Pregnancy Test, with the predicate device, OSOM hCG Urine Test (K974159)
Clinical Performance Data.
Professional evaluations were conducted considering the proposed device intended use, intended users, and intended use environments.
All studies were completed by lay-users and professional staff members at 4 women's health clinics. Lia performed two studies with 174 lay-user consumers between the ages of 18 – 49 to determine lay-person usability. In each study, devices from three manufacturing lots of Lia tests were used.
For the Lia Clinical Study, a total of N=1 53 women, attending four different women's health clinics, self-performed the Lia Pregnancy Test according to Package Insert instructions. Approximately half of the subjects were suspected to be pregnant. Lay-users collected a mid-stream sample on the Lia Pregnancy Test and a small aliquot in a specimen cup. The later sample was tested with the predicate device in clinical lab by a professional. The lay-user recorded their interpretation of the Lia Pregnancy Test results and then a clinical staff member examined and reported their interpretation of Lia Pregnancy Test results. Samples were randomly collected at various times throughout the day. Ages of these women ranged from 18 to 49 years.
The conformity between the user interpretation of the Lia Pregnancy Test and the staff interpretation of the Lia Pregnancy Test is 98.7%. The conformity between the staff interpretation of the Lia Pregnancy and the standard of care is 100%.
Data analysis shows that lay-users can successfully interpret the results, and that the test results were 100% concordant with the standard of care. In the post test questionnaire users report that the test is easy to use and the instructions are easy to understand. In the questionnaire answered after subjects used the test. 98% of lay-users said that the printed instructions were clear and usable. 91% of participants were confident that they had performed the test correctly. 98% said it was easy to use the test.
In an additional lay user study, 15 women performed simulated mid-stream tests with samples provided by Lia at defined hCG concentrations, close to the cutoff. In this study, 15 lay-users tested three different samples (2, 33, and 100mlU/mL) on three different lots of the Lia Pregnancy Test. Users were "blinded" as to sample status, and recorded their interpretation of the results. 100% of users correctly identified positive and neqative results.
10
As a result of clinical usability validations involving performance testing, data was gathered to support our assessment that the risk of harm has been adequately mitiqated and no unacceptable risks or unacceptable use related hazards related to the Lia Pregnancy Test were identified.
Conclusion Regarding Substantial Equivalence
The proposed device, Lia Pregnancy Test, is a pregnancy test for over-thecounter use intended for the qualitative identification of the elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy. The Lia Pregnancy Test has the same intended use, incorporates the same fundamental technology as the predicate, uses similar material and has essentially the same design as the predicate device, OSOM hCG Urine Test (K974159)
Test data to verify the performance of the proposed device, Lia Pregnancy Test, has been provided including:
-
Precision/Reproducibility
-
Cross-reactivity
-
Interfering Substances
-
Limit of Detection
-
Stability/Shelf Life
-
Effects of Urine pH & Urine Specific Gravity
-
High Dose Hook Effect
- . Beta hCG Core Fragment
The results of this performance testing, combined with the design and intended use comparison with the predicate device, OSOM hCG Urine Test (K974159), support substantial equivalence to, the predicate device, OSOM hCG Urine Test (K974159).