LogoFDA 510(k) Search
K Number
K123844
Device Name
CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST
Manufacturer
CHEMTRON BIOTECH, INC.
Date Cleared
2013-05-30

(168 days)

Product Code
JHI
Regulation Number
862.1155
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Chemtrue® hCG urine or Combo test is a rapid lateral flow immunoassay for the visual qualitative detection of human chorionic gonadotropin (hCG) in human urine or serum as an aid in the early determination of pregnancy. The Dipstick/Cassette and Combo Tests are for prescription use only, including at physician's offices or other Point-Of-Care sites (POC).
Device Description
The Chemtrue® hCG urine test is designed in Dipstick and Cassette formats. The hCG Combo (Serum/Urine) test is available in Cassette format only. Each test device consists of one (1) individual test strip and each test strip in the device consists of: 1) A conjugate pad contains colloidal gold conjugated with monoclonal anti-hCG antibody specific to the beta subunit of hCG. 2) A nitrocellulose membrane which is striped with the specific goat anti-hCG in the test line (T line) and goat anti-mouse antibody in the control line (C line serves as an internal quality control of the system and appears as a colored band during the test regardless of the hCG level in the test sample. All the configurations have the same membrane format, reagents and gold conjugate pad, as well as the same flow characteristics, except the test line in the nitrocellulose membrane for hCG Combo test is striped with polyclonal goat anti-hCG antibodies. Devices are packaged one device per foil pouch and 25 devices in each kit.
More Information

K990578, K964461

Not Found

No
The device is a rapid lateral flow immunoassay that relies on visual interpretation of colored bands. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI or ML.

No.
This device is designed for the detection of hCG as an aid in the early determination of pregnancy, making it a diagnostic tool, not a therapeutic device.

Yes
The device is described as "a rapid lateral flow immunoassay for the visual qualitative detection of human chorionic gonadotropin (hCG) in human urine or serum as an aid in the early determination of pregnancy." This explicitly states its purpose as assisting in diagnosis, making it a diagnostic device.

No

The device description clearly outlines physical components like a conjugate pad, nitrocellulose membrane, and test strip, indicating it is a hardware-based immunoassay test.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states "for the visual qualitative detection of human chorionic gonadotropin (hCG) in human urine or serum as an aid in the early determination of pregnancy." This describes a test performed in vitro (outside the body) on biological samples (urine or serum) to provide diagnostic information (pregnancy determination).
  • Device Description: The description details a "rapid lateral flow immunoassay" that uses reagents (antibodies, colloidal gold) to interact with components in the sample. This is a common format for IVD tests.
  • Sample Type: The device is designed to test "human urine or serum," which are biological specimens.
  • Performance Studies: The document includes detailed descriptions of performance studies such as Sensitivity, Reproducibility, and Method Comparison, which are standard evaluations for IVD devices to demonstrate their analytical and clinical performance.
  • Predicate Devices: The mention of predicate devices (K990578 and K964461) indicates that this device is being compared to other legally marketed IVD pregnancy tests.

All these characteristics align with the definition and typical features of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

Chemtrue® hCG Pregnancy Urine Dipstick Test: The Chemtrue® hCG Pregnancy Urine Dipstick Test is a rapid lateral flow qualitative immunoassay for early detection of human chorionic gonadotropin (hCG) in human urine in the device format of Dipstick. The test is designed to aid early detection of pregnancy. The device is intended for Prescription Use Only. The test kits are intended for prescription use including at physician's offices or other Point-Of-Care sites (POC).

Chemtrue® hCG Pregnancy Urine Cassette Test: The Chemtrue® hCG Pregnancy Urine Cassette Test is a rapid lateral flow qualitative immunoassays for early detection of human chorionic gonadotropin (hCG) in human urine in the device format of Cassette format. The test is designed to aid early detection of-pregnancy .- The device is intended for Prescription Use. Only .- The test kits are intended for prescription use including at physician's offices or other Point-Of-Care sites (POC).

Chemtrue® hCG Combo (Serum/Urine) Cassette Test: The Chemtrue® hCG Combo (Serum/Urine) Cassette Test is rapid lateral flow qualitative immunoassays for early detection of human chorionic gonadotropin (hCG) in human urine or serum in Cassette format only. The test is designed to aid early detection of pregnancy. The devices are intended for Prescription Use Only. The test kits are for prescription use including professionals at physician's office laboratories (POLs) or Point-Of-Care site (POC).

Product codes (comma separated list FDA assigned to the subject device)

JHI

Device Description

The Chemtrue® hCG urine test is designed in Dipstick and Cassette formats. The hCG Combo (Serum/Urine) test is available in Cassette format only. Each test device consists of one (1) individual test strip and each test strip in the device consists of:

  1. A conjugate pad contains colloidal gold conjugated with monoclonal anti-hCG antibody specific to the beta subunit of hCG.
  2. A nitrocellulose membrane which is striped with the specific goat anti-hCG in the test line (T line) and goat anti-mouse antibody in the control line (C line serves as an internal quality control of the system and appears as a colored band during the test regardless of the hCG level in the test sample.
    All the configurations have the same membrane format, reagents and gold conjugate pad, as well as the same flow characteristics, except the test line in the nitrocellulose membrane for hCG Combo test is striped with polyclonal goat anti-hCG antibodies.
    Devices are packaged one device per foil pouch and 25 devices in each kit.
    Human source materials was tested by FDA approved methods and found to be negative for the presence of antibodies to HIV-1, HIV-2, HbsAg and HCV.

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

Not Found

Intended User / Care Setting

physician's offices or other Point-Of-Care sites (POC), professionals at physician's office laboratories (POLs)

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

  1. Sensitivity (Cutoff Characteristics):
  • Study Type: Sensitivity (Cutoff Characteristics)
  • Sample Size: 15 samples tested per hCG concentration per lot.
  • Data Source: hCG urine pool from non-pregnant donors, spiked with hCG traceable to WHO 50 IS (07/364). hCG concentrations confirmed by Abbott i2000 instrument.
  • Annotation Protocol: Controls were blind coded. Five (5) replicates tested at each hCG control level by three (3) operators at 5 minutes read time.
  • Key Results:
    • Chemtrue® hCG Dipstick Pregnancy Test: 15/15 positive at 20 mIU/mL (Cutoff), 3/15 positive at 15 mIU/mL (-25% Cutoff), 0/15 positive at 10 mIU/mL (-50% Cutoff) and 0 mIU/mL. All 15/15 positive at 40 mIU/mL and 80 mIU/mL.
    • Chemtrue® hCG Cassette Pregnancy Test: 15/15 positive at 20 mIU/mL (Cutoff), 3/15 positive at 15 mIU/mL (-25% Cutoff), 0/15 positive at 10 mIU/mL (-50% Cutoff) and 0 mIU/mL. All 15/15 positive at 40 mIU/mL and 80 mIU/mL.
    • Chemtrue® hCG Combo (Urine) Test: 15/15 positive at 25 mIU/mL (Cutoff), 3/15 positive at 20 mIU/mL (-20% Cutoff), 0/15 positive at 10 mIU/mL (-60% Cutoff) and 0 mIU/mL. All 15/15 positive at 50 mIU/mL and 100 mIU/mL.
    • Chemtrue® hCG Combo (Serum) Test: 15/15 positive at 25 mIU/mL (Cutoff), 3/15 positive at 20 mIU/mL (-20% Cutoff), 0/15 positive at 10 mIU/mL (-60% Cutoff) and 0 mIU/mL. All 15/15 positive at 50 mIU/mL and 100 mIU/mL.
    • Conclusion: Confirmed claimed cutoff (sensitivity/detection limit) levels and consistent functional performance between lots for all device formats/configurations.
  1. Reproducibility (Precision) Study:
  • Study Type: Reproducibility (Precision) Study
  • Sample Size: Controls tested with hCG spiked at specified concentrations. Each concentration tested with three (3) lots, by nine (9) operators across three (3) POL sites over three (3) non-consecutive days.
  • Data Source: Blind coded controls with hCG spiked in urine and serum, calibrated against WHO 50th IS (07/364) and confirmed with Abbott i2000.
  • Annotation Protocol: Every device tested and interpreted by the same operator at 5 minutes read time.
  • Key Results:
    • hCG Dipstick Test (Cut-off 20 mIU/mL): 27/27 positive at 20 mIU/mL and above (25, 30, 35 mIU/mL), 3/27 positive at 15 mIU/mL, 0/27 positive at 0 and 10 mIU/mL. Consistent results across sites.
    • hCG Cassette Test (Cut-off 20 mIU/mL): 27/27 positive at 20 mIU/mL and above, 2/27 positive at 15 mIU/mL, 0/27 positive at 0 and 10 mIU/mL. Consistent results across sites.
    • hCG Combo Urine Test (Cut-off 25 mIU/mL): 27/27 positive at 25 mIU/mL and above (30, 35 mIU/mL), 5/27 positive at 20 mIU/mL, 0/27 positive at 0 and 15 mIU/mL. Consistent results across sites.
    • hCG Combo Serum Test (Cut-off 25 mIU/mL): 27/27 positive at 25 mIU/mL and above, 5/27 positive at 20 mIU/mL, 0/27 positive at 0 and 15 mIU/mL. Consistent results across sites.
    • Conclusion: Consistent functional performance between sites and device formats/configurations. Performance similar between nine (9) operators across all three (3) study sites.
  1. Method Comparison Study:
  • Study Type: Method Comparison Study
  • Sample Size: 300 clinical urine samples (150 hCG negative, 150 hCG positive) for urine tests. 50 hCG negative serum samples and 50 hCG positive serum samples for combo test.
  • Data Source: Clinical urine samples from women of childbearing age (including peri-menopausal), hCG positive samples from women suspected pregnant within first 30 days/first trimester. hCG positive serum samples quantitatively confirmed by Abbott i2000.
  • Annotation Protocol: Samples blind coded and tested with each device format by nine (9) operators from three (3) POL sites in Shanghai China. Each site tested 100 samples with unique blind codes.
  • Key Results:
    • Chemtrue hCG Pregnancy Urine Dipstick Test (Cutoff: 20 mIU/mL): Total Agreement 100%. Sensitivity = 100%, Specificity = 100%.
    • Chemtrue hCG Pregnancy Urine Cassette Test (Cutoff: 20 mIU/mL): Total Agreement 99.7%. Sensitivity = 100%, Specificity = 99.3%. One discrepant result from a single sample near cutoff.
    • Chemtrue® hCG Combo Pregnancy Serum Test (Cutoff: 25 mIU/mL): Total Agreement 100%. Sensitivity = 100%, Specificity = 100%.
    • Chemtrue® hCG Combo Pregnancy Urine Test (Cutoff: 25 mIU/mL): Total Agreement 100%. Sensitivity = 100%, Specificity = 100%.
    • Accuracy Assessment: Overall 99.8% agreement within site and between sites.
  1. Analytical Specificity (Cross-Reactivity and Interference):
  • Study Type: Cross-reactivity and Interference Studies
  • Study Details: Cross-reactivity with hLH, hFSH, hTSH, and various endogenous/exogenous substances. Interference with hCGBcf and effect of specific gravity (SG) and pH.
  • Key Results:
    • No cross-reactivity with hLH up to 300 mIU/mL, hFSH up to 1000 mIU/mL, and hTSH up to 1000 mIU/mL.
    • No interference with various chemical substances at tested concentrations (e.g., Acetylsalicylate Acid 20 mg/dL, Albumin 2000 mg/dL, Bilirubin 2 mg/dL, Glucose 2000 mg/dL, Hemoglobin 250 mg/dL).
    • hCGBcf up to 1,000,000 pmol/mL does not interfere.
    • No interference observed for pH values 2.0 to 9.0 and SG values from 1.003 to 1.030.
  1. High Dose (Hook Effect):
  • Study Type: High Dose (Hook Effect) Study
  • Sample Size: Five replicates of each lot were tested at each hCG concentration.
  • Data Source: Spiked non-pregnant urine and serum pools at hCG concentrations of 50, 100, 200, 300 and 500 IU/mL.
  • Key Results: No hook effect observed with hCG concentrations up to 500 IU/mL in urine and serum for hCG urine and Combo tests in all formats.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

  • Sensitivity (Chemtrue hCG Pregnancy Urine Dipstick Test): 100%
  • Specificity (Chemtrue hCG Pregnancy Urine Dipstick Test): 100%
  • Sensitivity (Chemtrue " hCG Pregnancy Urine Cassette Test): 100%
  • Specificity (Chemtrue " hCG Pregnancy Urine Cassette Test): 99.3%
  • Sensitivity (Chemtrue® hCG Combo Pregnancy Serum Test): 100%
  • Specificity (Chemtrue® hCG Combo Pregnancy Serum Test): 100%
  • Sensitivity (Chemtrue® hCG Combo Pregnancy Urine Test): 100%
  • Specificity (Chemtrue® hCG Combo Pregnancy Urine Test): 100%
  • Overall Agreement (Accuracy assessment within site and between sites): 99.8%

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K990578, K964461

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

MAY 3 0 2013

Final 510(k) Summary

(K123844)

Chemtrue® Human Chorionic Gonadotropin (hCG) Pregnancy Test

With the following configurations:

  • Chemtrue® hCG Pregnancy Urine Dipstick Test 1.
    1. Chemtrue® hCG Pregnancy Urine Cassette Test
  • Chemtrue® hCG Combo (Serum/Urine) Cassette Test 3.

Prepared By: Jane Zhang, Director of QA/RA Sponsor: Chemtron Biotech, Inc. 8370 Juniper Creek Lane, Suite 1-2 San Diego, CA 92126 Office phone: (858) 530-2868 Mobile phone: (858) 997-7472 Fax (858) 530-2878

Date: May 30, 2013

1

510(k) Summary

AS REQUIRED BY 21 CFR 807.92(c)

The Assigned 510(k) number is K123844

Date of Summary: May 30, 2013

Purpose for Submission: New Device

Measurand: Human Chorionic gonadotropin (hCG) in human urine / serum

Type of Test: Qualitative

Applicant: Chemtron Biotech, Inc.

Trade/Proprietary Name:

Chemtrue® hCG Pregnancy Urine Dipstick Test Chemtrue® hCG Pregnancy Urine Cassette Test Chemtrue® hCG Combo (Serum/Urine) Cassette Test

Regulatory Information:

    1. Regulation section: 21CFR §862.1155, human chorionic gonadotropin (hCG) test system.
    1. Identification: An hCG test system is intended for the early detection of pregnancy. It is intended to measure hCG, a placental hormone, in urine or serum.
    1. Classification: II
  1. Product code: JHI

Panel: Clinical Chemistry (75)

Proposed Labeling or Promotional Material for the Device:

A description of the device can be found in the attached proposed labeling, including an explanation of how the device functions, technical principle and concepts that form the basis for the device, as well as the physical and performance characteristics of the device, such as the device design, materials used and physical properties. In accordance with FDA labeling requirements (21 CFR 809.10), enclosed are the draft copies of product labeling including copies of the technical product inserts.

Intended Use

See indications for use below. The Chemtrue® hCG urine or Combo test is a rapid lateral flow immunoassay for the visual qualitative detection of human chorionic gonadotropin (hCG) in human urine or serum as an aid in the early determination of pregnancy. The Dipstick/Cassette and Combo Tests are for prescription use only, including at physician's offices or other Point-Of-Care sites (POC).

Indication(s) for Use:

Chemtrue® hCG Pregnancy Urine Dipstick Test

2

The Chemtrue® hCG Pregnancy Urine Dipstick Test is a rapid lateral flow qualitative immunoassay for early detection of human chorionic gonadotropin (hCG) in human urine in the device format of Dipstick. The test is designed to aid early detection of pregnancy. The device is intended for Prescription Use Only.

The test kits are intended for prescription use including at physician's offices or other Point-Of-Care sites (POC).

Chemtrue® hCG Pregnancy Urine Cassette Test

The Chemtrue® hCG Pregnancy Urine Cassette Test is a rapid lateral flow qualitative immunoassays for early detection of human chorionic gonadotropin (hCG) in human urine in the device format of Cassette format. The test is designed to aid early detection of pregnancy. The device is intended for Prescription Use Only.

The test kits are intended for prescription use including at physician's offices or other Point-Of-Care sites (POC).

Chemtrue hCG Combo (Serum/Urine) Cassette Test

The Chemtrue® hCG Combo (Serum/Urine) Cassette Test is rapid lateral flow qualitative immunoassays for early detection of human chorionic gonadotropin (hCG) in human urine or serum in Cassette format only. The test is designed to aid early detection of pregnancy. The devices are intended for Prescription Use Only.

The test kits are for prescription use including professionals office laboratories (POLS) or Point-Of-Care site (POC).

3

Special conditions for use statement(s):

The devices are for prescription use.

Special instrument requirements: None

Device Description:

The Chemtrue® hCG urine test is designed in Dipstick and Cassette formats. The hCG Combo (Serum/Urine) test is available in Cassette format only. Each test device consists of one (1) individual test strip and each test strip in the device consists of:

    1. A conjugate pad contains colloidal gold conjugated with monoclonal anti-hCG antibody specific to the beta subunit of hCG.
    1. A nitrocellulose membrane which is striped with the specific goat anti-hCG in the test line (T line) and goat anti-mouse antibody in the control line (C line serves as an internal quality control of the system and appears as a colored band during the test regardless of the hCG level in the test sample.

All the configurations have the same membrane format, reagents and gold conjugate pad, as well as the same flow characteristics, except the test line in the nitrocellulose membrane for hCG Combo test is striped with polyclonal goat anti-hCG antibodies.

Devices are packaged one device per foil pouch and 25 devices in each kit.

Human source materials was tested by FDA approved methods and found to be negative for the presence of antibodies to HIV-1, HIV-2, HbsAg and HCV.

Substantial Equivalence Information:

The Chemtrue® hCG Pregnancy Urine Dipstick/Cassette Test and hCG Combo Test are substantially equivalent to other tests currently on the market.

  1. Predicate device name(s) and 510(k) number(s):
Predicate Device Name510(k) k number
Genzyme Diagnostics OSOM® Card hCG Urine TestK990578
Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card TestK964461
  1. Comparison with predicate:

The Chemtrue® hCG Pregnancy test device is similar to the predicate(s) with regard to the technology principle, indication for use, detection limit and sample matrix, etc. The candidate device and the predicates are both visually-read single use devices. The similarities and differences among these tests are summarized as follows:

2-a. hCG urine Tests:

ItemSIMILARITIES
Proposed DevicePredicate Device
ItemChemtrue® hCG Pregnancy
Urine TestsOSOM® Card hCG Urine Test
K990578
Intended UseA rapid qualitative immunoassay
for rapid determination ofSame

4

:

| | human chorionic gonadotropin
(hCG) to aid in the early
detection of pregnancy | |
|------------------------------------|---------------------------------------------------------------------------------------|------|
| Technology principle | Lateral-flow immunoassay | Same |
| Indication of Use | For prescription use, including
professionals at physician's
office labs (POLs) | Same |
| Specimen matrix | Human urine | Same |
| Results | Qualitative | Same |
| Result Interpretation | Visually-read line intensity | Same |
| Sensitivity/Cutoff characteristics | 20 mIU/mL | Same |
| Quality Control | Built-in Internal Control | Same |

DIFFERENCES
ItemProposed DevicePredicate Device
Chemtrue® hCG PregnancyOSOM® Card hCG Urine Test
Urine TestK990578
Read timeRead the results at 5 minutes.Read the results at 3 minutes.
Device formatDipstick and CassetteCassette only
Storage4°C - 30°C15°C -30°C

2-b. hCG Combo Test:

SIMILARITIES
Proposed Device
Chemtrue® hCG Combo
(Urine/Serum) Cassette TestPredicate Device
Teco Diagnostics One-Step
Urine/Serum Combo Pregnancy
Card Test K964461
Item
Intended UseA rapid qualitative immunoassay
for rapid determination of
human chorionic gonadotropin
(hCG) to aid in the early
detection of pregnancySame
Technology principleLateral-flow immunoassaySame
Indication of UseFor prescription use, including
professionals at physician's
office labs (POLs)Same
Specimen matrixHuman urine or serumSame
ResultsQualitativeSame
Result InterpretationVisually-read line intensitySame
Read timeRead the results at 5 minutesSame
Sensitivity/Cutoff characteristics25 mIU/mLSame
Quality ControlBuilt-in Internal ControlSame

| | A to many as and i an i a ca
LEAR S. MINE MAR LIES
THE ORDENCES
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
|----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| ltems
And And Analy Company of Children Comments of Children Comments of Children

| Pronosed Device | 1
C
Predicate Device |

5

| | Chemtrue® hCG Combo
(Urine/Serum) Test | Teco Diagnostics One-Step
Urine/Serum Combo Pregnancy
Card Test K964461 |
|---------|-------------------------------------------|-------------------------------------------------------------------------------|
| Storage | 4°C – 30°C | 18°C - 30°C or refrigerated (2-
8°C) |

Standard/Guidance Document Referenced (if applicable):

  • FDA guidance: Review Criteria for Assessment of Professional Use Human Chorionic . Gonadotropin (hCG) In Vitro Diagnostic Devices - Document Issued on: November 6, 1996.
  • National Committee for Clinical Laboratory Standards. Evaluation of precision performance of . clinical chemistry devices; tentative guideline - Second Edition. NCCLS Document EP5-T2. Wayne, PA: NCCLS, 1992.
  • CLSI EP7-A2: Interference Testing in Clinical Chemistry ●
  • ISO 14971:2007, Medical Devices-Application of Risk Management to Medical Devices .

Test Principle:

The device employs lateral flow immunoassay technology for detection of human chorionic gonadotropin (hCG) in urine and or serum. Monoclonal for hCG Combo) goat anti-hCG antibodies are pre-striped in the nitrocellulose membrane on the test region (T line) and goat antimouse antibodies on the control region (C line). During testing, the urine/serum specimen reacts with the conjugate pad (It contains colloidal gold particles conjugated with monoclonal anti-hCG antibody specific to the beta subunit of hCG) located just beneath the sample pad and above the membrane of the test strip. The specimen migrates upward on the membrane by capillary action to react with the antibodies on the membrane. If the hCG concentration in at or above the designated detection limit, a red colored line at the test region will be present indicating a positive result, while its absence indicates a negative result. The control line (C line) serves as an internal quality control. The control line should always appear, regardless of the hCG concentration of the test specimen, and the C line is an indicator that sufficient sample volume has been added to the test device and the sample has correctly migrated up the test strip.

Performance Characteristics

Chemtron Biotech, Inc. has reviewed the FDA guidance documents "Review Criteria for Assessment of Professional Use Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs) -Document Issued on: November 6, 1996" and CFR809.10 labeling regulations and conducted the studies listed in the notification were conducted, including the design of draft labeling and package inserts.

  1. Sensitivity (Cutoff Characteristics): Three (3) lots of each device formats were used for the study with spiked hCG urine pool from non-pregnant donors. The hCG was traceable to WHO 50 IS (07/364) at the concentrations of 0, 10,15,20,40 and 80 mIU/mL. The hCG concentrations were quantitatively confirmed by Abbott i2000 instrument. The controls were blind coded. Separate sets of the blind codes were assigned for each device format, Dipstick, Cassette and hCG Combo Test. Five (5) replicates

6

were tested at each hCG control level by three (3) operators at 5 minutes as the read time, per package insert request. The results are summarized in tables below:

| hCG Conc.
(mIU/mL) | # of Samples
Tested | Lot 1 | | Lot 2 | | Lot 3 | | # of Positives |
|-----------------------|------------------------|-------|---|-------|---|-------|---|----------------|
| | | + | - | + | - | + | - | |
| 0 | 15 | 0 | 5 | 0 | 5 | 0 | 5 | 0/15 |
| 10 (-50% Cutoff) | 15 | 0 | 5 | 0 | 5 | 0 | 5 | 0/15 |
| 15 (-25% Cutoff) | 15 | 1 | 4 | 1 | 4 | 1 | 4 | 3/15 |
| 20 (Cutoff) | 15 | 5 | 0 | 5 | 0 | 5 | 0 | 15/15 |
| 40 (+200% Cutoff) | 15 | 5 | 0 | 5 | 0 | 5 | 0 | 15/15 |
| 80 (+400% Cutoff) | 15 | 5 | 0 | 5 | 0 | 5 | 0 | 15/15 |

Table 1-a. Results of Chemtrue® hCG Dipstick Pregnancy Test:

Table 1-b. Results of Chemtrue® hCG Cassette Pregnancy Test:

| hCG Conc.
(mIU/mL) | # of Samples
Tested | Lot 1 | | Lot 2 | | Lot 3 | | # of Positives |
|-----------------------|------------------------|-------|---|-------|---|-------|---|----------------|
| | | + | - | + | - | + | - | |
| 0 | 15 | 0 | 5 | 0 | 5 | 0 | 5 | 0/15 |
| 10 (-50% Cutoff) | 15 | 0 | 5 | 0 | 5 | 0 | 5 | 0/15 |
| 15 (-25% Cutoff) | 15 | 1 | 4 | 1 | 4 | 1 | 4 | 3/15 |
| 20 (Cutoff) | 15 | 5 | 0 | 5 | 0 | 5 | 0 | 15/15 |
| 40 (+200% Cutoff) | 15 | 5 | 0 | 5 | 0 | 5 | 0 | 15/15 |
| 80 (+400% Cutoff) | 15 | 5 | 0 | 5 | 0 | 5 | 0 | 15/15 |

Chemtrue® hCG Combo Test: Three (3) lots of test devices were used for the study. The controls were prepared using spiked hCG in twenty (20) non-pregnant human serum and urine pools, respectively. The hCG controls were traceable to WHO 5th IS (07/364). The following six (6) hCG concentrations were used for the study:

hCG Concentration (mIU/mL) in SerumhCG Concentration (mIU/mL) in Urine
00
1010
2020
2525
5050
100100

Results:

Table 2-a. Chemtrue® hCG Combo (Urine) Test:

hCG Conc. (mIU/mL)# of Samples TestedLot 1Lot 2Lot 3# of Positives
+-+-+-
0150505050/15
10 (-60% Cutoff)150505050/15
20 (-20% Cutoff)151414143/15
25 (Cutoff)1550505015/15
50 (+200% Cutoff)1550505015/15
100 (+400% Cutoff)1550505015/15

7

| hCG Conc.
(mIU/mL) | # of Samples
Tested | Lot 1 | | Lot 2 | | Lot 3 | | # of Positives |
|-----------------------|------------------------|-------|---|-------|---|-------|---|----------------|
| 0 | 15 | + | - | + | - | + | - | |
| 0 | 15 | 0 | 5 | 0 | 5 | 0 | 5 | 0/15 |
| 10 (-60% Cutoff) | 15 | 0 | 5 | 0 | 5 | 0 | 5 | 0/15 |
| 20 (-20% Cutoff) | 15 | 1 | 4 | 1 | 4 | 1 | 4 | 3/15 |
| 25 (Cutoff) | 15 | 5 | 0 | 5 | 0 | 5 | 0 | 15/15 |
| 50 (+200% Cutoff) | 15 | 5 | 0 | 5 | 0 | 5 | 0 | 15/15 |
| 100 (+400% Cutoff) | 15 | 5 | 0 | 5 | 0 | 5 | 0 | 15/15 |

Table 2-b. Chemtrue® hCG Combo (Serum) Test:

CONCLUSION: The results confirmed the claimed cutoff (sensitivity/detection limit) levels for the Chemtrue " hCG Tests in Dipstick/Cassette configurations, as well as the hCG Combo Test. Also the results demonstrated that the functional performance is consistent between lot-to-lot of all the device formats/ configurations.

Linearity/assav reportable range: Linearity is not applicable since this is a qualitative test.

Traceability, Stability, Expected values (controls, calibrators, or methods): Chemtrue® hCG Pregnancy Tests are calibrated against reference material traceable to WHO International Standard 5th edition.

A shelf-life stability test of the devices was performed in real-time and accelerated testing. The results showed that the devices were stable for 24 months when stored at 25°C±2°C in the sealed foil pouch. Protocol and acceptance criteria were reviewed and are acceptable.

The sensitivity was evaluated in conjunction with the Cut-off characteristics and precision testing. Refer to the precision data in section 2 below. The detection limit was demonstrated to be 20 mIU/mL for urine test and 25 mIU/mL for hCG Combo test.

  1. Reproducibility (Precision) Study: The study was conducted in three (3) POL sites by a total of nine (9) operators and three (3) operators for each site with three (3) lots of each proposed device formats over three (3) non-consecutive days. The blind coded controls were used with hCG spiked at the concentrations of 0, 10, 15, 20, 25, 30 and 35 mIU/mL in urine; 0, 15, 20, 25, 30 and 35 mIU/mL in serum (Used for hCG Combo Test). The controls were calibrated against WHO 50" IS (07/364) and the values were confirmed with a FDA cleared Abbott chemiluminescent quantitative immunoassay, i2000 (Abbott Park, Illinois, 60064-3500, U.S.A). Every device was tested and interpreted by the same operator at 5 minutes as the read time, per package insert request. The reproducibility between the sites is summarized in tables below:
SitesTOTAL
123+-
hCG
concentration
(mIU/mL)Spec.+-+-+-+-
0090909027
10 (-50%cutoff)090909027
15 (-25%cutoff)181818324

Table 3: hCG Dipstick Test (Cut-off 20 mIU/mL)

8

Chemtron Biotech, Inc. Final 510(k) Summary K123844

20 (Cut-off)909090270
25 (+25%cutoff)909090270
30 (+50%cutoff)909090270
35 (+75%cutoff)909090270

Table 4. hCG Cassette Test (Cut-off 20 mIU/mL)

SitesTOTAL
123
Spec.+-+-+-+-
hCG
concentration
(mIU/mL)0090909027
10 (-50%cutoff)090909027
15 (-25%cutoff)091818225
20 (Cut-off)909090270
25 (+25%cutoff)909090270
30 (+50%cutoff)909090270
35 (+75%cutoff)909090270

Table 5. hCG Combo Urine Test (Cut-off 25 mIU/mL)

SitesTOTAL
123+-
Spec.+-+-+-+-
hCG
concentration
(mIU/mL)0090909027
15 (-40% cutoff)090909027
20 (-20% cutoff)182727522
25 (Cut-off)909090270
30 (+20% cutoff)909090270
35 (+40% cutoff)909090270

Table 6. hCG Combo Serum Test (Cut-off 25 mIU/mL)

SitesTOTAL
Spec.1 +1 -2 +2 -3 +3 -+-
0090909027
hCG
concentration
(mIU/mL)15 (-40% cutoff)090909027
20 (-20% cutoff)271827522
25 (Cut-off)909090270
30 (+20% cutoff)909090270
35 (+40% cutoff)909090270

9

ConfigurationsTOTAL
Spec.Cassette +Cassette -Dipstick +Dipstick -+-
hCG
concentration
(mIU/mL)0027027054
10 (-50%cutoff)027027054
15 (-25%cutoff)225324549
20 (Cut-off)270270540
25 (+25% cutoff)270270540
30 (+50% cutoff)270270540
35 (+75% cutoff)270270540
Table 7. Comparison among two device formats for Chemtrue® hCG urine Tests

CONCLUSION: The results demonstrate a consistent functional performance of the Chemtrue® hCG Tests between the sites and device formats/configurations.

Reproducibility study data among the operators: The results demonstrate that the performance of each Chemtrue® hCG Test format was similar between nine (9) operators across all three (3) study sites.

  1. Method Comparison Study Data Summary: Chemtrue® hCG Pregnancy Tests were compared with the Predicate kits. A total of 300 clinical urine samples were blind coded and tested with each device format by nine (9) operators from three (3) POL sites (three operators in each site) in Shanghai China. One hundred-fifty (150) hCG negative urine samples (collected from women of childbearing age, including peri-menopausal) and 150 hCG positive samples that represented women who were suspected to be pregnant within the first 30 days of pregnancy/the first trimester of pregnancy in the early pregnancy and late pregnancy. 50 hCG negative serum samples and 50 hCG positive serum samples that are representative for the populations of the intended use were used for the study. The hCG positive serum samples were quantitatively confirmed by Abbott i2000 instrument. Each specimen was evenly split into three aliquots. Each site tested 100 samples with a unique set of blind codes for each device formation. The results are summarized in tables below: Table 8. Chemtrue hCG Pregnancy Urine Dipstick Test (Cutoff: 20 mIU/mL)

| | | Predicate Device
OSOM® Card hCG Urine Test (K990578) | | Total Agreement
% |
|-----------------------------------------|----------|---------------------------------------------------------|----------|----------------------|
| | | Positive | Negative | |
| Chemtrue® hCG
Dipstick Test
N=300 | Positive | 150 | 0 | |
| | Negative | 0 | 150 | 100% |
| | Total | 150 | 150 | |

Sensitivity = (150 / (60+90)) x100 = 100%; Specificity = (150 / (150+0)) x 100 = 100% Table 9. Chemtrue " hCG Pregnancy Urine Cassette Test (Cutoff: 20 mIU/mL)

| Predicate Device
OSOM® Card hCG Urine Test (K990578) | Total Agreement
% |
|---------------------------------------------------------|----------------------|
| Positive | Negative |

10

Chemtrue® hCGPositive149
Cassette TestNegative1 2099.7%
N=300Total150150
्11 10 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 114 20 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 11 4 A A 4
AA AAI

Sensitivity = (149 / (59+90+0)) x100 = 100%; Specificity = (150 / (150+1)) x 100 = 99.3%

One discrepant result in this table was from a single sample with a hCG concentration near the cut-off of the device (20 mIU/mL).

Table 10. Chemtrue® hCG Combo Pregnancy Serum Test (Cutoff: 25 mIU/mL)

| | | Predicate Device
One-Step Urine/Serum Combo Pregnancy Card Test
(K964461) | | Total
Agreement |
|--------------------------------------------|----------|---------------------------------------------------------------------------------|----------|--------------------|
| | | Positive | Negative | |
| Chemtrue® hCG
Combo Serum Test
N=300 | Positive | 150 | 0 | |
| | Negative | 0 | 150 | 100% |
| | Total | 150 | 150 | |

Sensitivity = (150 / (12+138)) x100 = 100%; Specificity = (150 / (150+0)) x 100 = 100%

Table 11. Chemtrue® hCG Combo Pregnancy Urine Test (Cutoff: 25 mIU/mL)

| | | Predicate Device
One-Step Urine/Serum Combo Pregnancy Card Test
(K964461) | | Total
Agreement |
|--------------------------------------------|----------|---------------------------------------------------------------------------------|----------|--------------------|
| | | Positive | Negative | |
| Chemtrue® hCG
Combo Urine Test
N=300 | Positive | 150 | 0 | |
| | Negative | 0 | 150 | 100% |
| | Total | 150 | 150 | |

Sensitivity = (150 / (60+90)) x100 = 100%; Specificity = (150 / (150+0)) x 100 = 100%

Discussion and Conclusion: Based on the technological principle, features of the device design, test specimen matrix, test method and performance characterizations, as the set forth above, it can be concluded that Chemtrue® hCG Pregnancy tests are substantially equivalent to the predicate kits which are currently distributed commercially.

Table 12. Accuracy assessment within site and between sites:

Site 1Site 2Site 3
AgreementWithin Site100%99.5%100%
Between Sites99.8%

Conclusion: The results demonstrate an overall 99.8% agreement within the site and between the sites. The device performance is substantially equivalent to the predicate kit OSOM® Card Pregnancy Test and other products that are presently distributed commercially.

4. Clinical studies:

11

a. Clinical Sensitivity: Not applicable

b. Clinical specificity: Not applicable

    1. Clinical cut-off: Not applicable
    1. Expected values/Reference range: Not applicable
  1. Analytical specificity: The cross-reactivity study was conducted with three (3) lots of each test format/configuration with spiked concentration of the structurally related or potential interfering substances in urine and serum hCG negative and 50 mIU/mL controls. The results demonstrate that the Chemtrue® hCG Tests do not cross react with hLH up to 300 mIU/mL, hFSH up to 1000 mIU/mL and hTSH up to 1000 mIU/mL. The following compounds do not interfere with Chemtrue® hCG Tests at the concentrations tested:
1able13.
SubstanceConcentration
Acetylsalicylate Acid20 mg/dL
Albumin (Human)2000 mg/dL
Ascorbic Acid20 mg/dL
Atropine20 mg/dL
Bilirubin2 mg/dL
Caffeine20 mg/dL
Cannabinol10 mg/dL
Ephedrine20 mg/dL
Gentisic Acid20 mg/dL
Glucose2000 mg/dL
Hemoglobin250 mg/dL
Ibuprofen40 mg/dL
Methadone10 mg/dL
Morphine6 $\mu$ g/dL
Phenylpropanolamine20 mg/dL
Salicylic acid20 mg/dL
Uric Acid20 mg/dL

The detailed data is summarized in Section "Performance Characteristics, Specificity", page 56 of 510(k) Submission.

An interference study with hCGBcf was also performed with three (3) lots each format at the concentrations 125,000, 250,000, 500,000 and 1,000,000 pmol/mL of hCGlocf that were added into 5 and 50 mIU/mL hCG urine and serum controls. The results are summarized in Table 14 below:

12

125,000 pmol/mL250,000 pmol/mL500,000 pmol/mL1,000,000 pmol/mL
hCG Conc.
in urineLot #1Lot #2Lot #3Lot #1Lot #2Lot #3Lot #1Lot #2Lot #3Lot #1Lot #2Lot #3
5 mIU/mL0/100/100/100/100/100/100/100/100/100/100/100/10
50 mIU/mL10/1010/1010/1010/1010/1010/1010/1010/1010/1010/1010/1010/10

Table 14-a. Interference study results with hCGBcf - Urine Dipstick Test

# of Positive Results with Concentrations of hCG βcf
125,000 pmol/mL250,000 pmol/mL500,000 pmol/mL1,000,000 pmol/mL
hCG Conc.
in urineLot
#1Lot
#2Lot
#3Lot
#1Lot
#2Lot
#3Lot
#1Lot
#2Lot
#3Lot
#1Lot
#2Lot
#3
5 mIU/mL0/100/100/100/100/100/100/100/100/100/100/100/10
50 mIU/mL10/1010/1010/1010/1010/1010/1010/1010/1010/1010/1010/1010/10

Table 15-a. Interference study results with hCGBcf - hCG Combo Urine Test

# of Positive Results with Concentrations of hCG βcf in Urine
125,000 pmol/mL250,000 pmol/mL500,000 pmol/mL1,000,000 pmol/mL
hCG Conc.
in urineLot
#1Lot
#2Lot
#3Lot
#1Lot
#2Lot
#3Lot
#1Lot
#2Lot
#3Lot
#1Lot
#2Lot
#3
5 mIU/mL0/100/100/100/100/100/100/100/100/100/100/100/10
50 mIU/mL10/1010/1010/1010/1010/1010/1010/1010/1010/1010/1010/1010/10

Table 15-b. Interference study results with hCGBcf - hCG Combo Serum Test

# of Positive Results with Concentrations of hCG βcf in Serum
hCG Conc.
in Serum125,000 pmol/mL250,000 pmol/mL500,000 pmol/mL1,000,000 pmol/mL
Lot #1Lot #2Lot #3Lot #1Lot #2Lot #3Lot #1Lot #2Lot #3Lot #1Lot #2Lot #3
5 mIU/mL0/100/100/100/100/100/100/100/100/100/100/100/10
50 mIU/mL10/1010/1010/1010/1010/1010/1010/1010/1010/1010/1010/1010/10

CONCLUSION: The results demonstrate that hCGBcf up to 1,000,000 pmol/mL does not interfere with the Chemtrue® hCG Tests.

The effect of specific gravity (SG) and pH were evaluated by testing duplicates at each sample level of hCG negative and 20 mIU/mL (25 mIU/mL for Combo Test) urine controls with pH 2.0 to 9.0, and SG of 1.003 to 1.030. No interference was observed for pH value 2.0 to 9.0 and SG values from 1.003 to 1.030. However, labeling states that low concentrations of hCG may not be detected in very dilute urine and, if pregnancy is suspected, testing should be repeated after 48 hours. The detailed data is enclosed in ATTACHMENT D, page 74 of the submission.

Flex studies were performed and include read time and sample volume verifications. The results support the claims in the package inserts. The study reports are presented in ATTACHMENT H, pages H9 to H25 of the submission.

13

  1. High dose (hook effect): The studies for both hCG Urine and Combo Tests were performed on three (3) lots of each test format with spiked non-pregnant urine and serum pools at hCG concentrations of 50, 100, 200, 300 and 500 IU/mL. Five replicates of each lot were tested at each hCG concentration. The results are summarized in Table 14 and 15 below:

Table 14. High Dose Effect Study Results Summary with hCG Urine Tests

| hCG Concentrations

(IU/mL)hCG Urine Tests
DipstickCassette
+-+-
50150150
100150150
200150150
300150150
500150150
TOTAL750750

Table 15. High Dose Effect Study Results Summary with hCG Combo (Urine/Serum) Test

| hCG
Concentrations

(IU/mL)hCG Combo Tests
Urine TestSerum Test
+-+-
50150150
100150150
200150150
300150150
500150150
TOTAL750750

Conclusion: No hook effect was observed with hCG concentrations up to 500 1U/mL in urine and serum for hCG urine and Combo tests in all the formats.

CONCLUSION:

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

14

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/14/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

Public Health Service

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

May 30, 2013

Chemtron Biotech, Inc. C/O Ms. Jane Zhang 8370 Juniper Creek Lane, Suite 1-2 SAN DIEGO CA 92126

Re: K123844

Trade/Device Name: Chemtrue® hCG Pregnancy Urine Dipstick Chemtrue® hCG Pregnancy Urine Cassette Test

Chemtrue® hCG Combo (Serum/Urine) Cassette Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: II Product Code: JHI Dated: April 29, 2013 Received: May 3, 2013

Dear Ms. Zhang:

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 801); medical device reporting (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.

15

Page 2-Ms. Zhang

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

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

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Carol C. Benson -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

16

Indications for Use

510(k) Number (if known): K123844

· Device Name: Chemtrue® hCG Pregnancy Urine Dipstick Chemtrue® hCG Pregnancy Urine Cassette Test Chemtrue® hCG Combo (Serum/Urine) Cassette Test

Indications for Use:

Chemtrue hCG Pregnancy Urine Dipstick Test

The Chemtrue® hCG Pregnancy Urine Dipstick Test is a rapid lateral flow qualitative immunoassay for early detection of human chorionic gonadotropin (hCG) in human urine in the device format of Dipstick. The test is designed to aid early detection of pregnancy. The device is intended for Prescription Use Only.

The test kits are intended for prescription use including at physician's offices or other Point-Of-Care sites (POC).

Chemtrue® hCG Pregnancy Urine Cassette Test

The Chemtrue® hCG Pregnancy Urine Cassette Test is a rapid lateral flow qualitative immunoassays for early detection of human chorionic gonadotropin (hCG) in human urine in the device format of Cassette format. The test is designed to aid early detection of-pregnancy .- The device is intended for Prescription Use. Only .-

The test kits are intended for prescription use including at physician's offices or other Point-Of-Care sites (POC).

Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Denise Johnson-Ivles -S 2013.05.30 11:07:17 -04′00″

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) K123844

17

Indications for Use

510(k) Number (if known): K123844

Device Name: Chemtrue® hCG Pregnancy Urine Dipstick Chemtrue® hCG Pregnancy Urine Cassette Test Chemtrue® hCG Combo (Serum/Urine) Cassette Test

Indications for Use:

Chemtrue® hCG Combo (Serum/Urine) Cassette Test:

The Chemtrue® hCG Combo (Serum/Urine) Cassette Test is rapid lateral flow qualitative immunoassays for early detection of human chorionic gonadotropin (hCG) in human urine or serum in Cassette format only. The test is designed to aid early detection of pregnancy. The devices are intended for Prescription Use Only.

The test kits are for prescription use including professionals at physician's office laboratories (POLs) or Point-Of-Care site (POC).

And/Or

Prescription Use X (21 CFR Part 801 Subpart D)

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Denise Johnson-lyles -S 2013.05.30 11:07:40 -04'00'

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) K123844