LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA

K040923 · Ibl GmbH · JLS · Jul 22, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040923
• Device Name: LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA
• Applicant: Ibl GmbH
• Product Code: JLS · Clinical Chemistry
• Decision Date: Jul 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1620
• Device Class: Class 1

Intended Use

Luminescence immunoassay for the in vitro diagnostic quantitative measurement of active free progesterone (a female hormone) in saliva. Measurements obtained by this device may be used in the diagnosis and treatment of disorders of the ovaries and can be used as an aid for confirmation of ovulation. The IBL SaliCap Set is used for the collection, handling, and storage of saliva used in the Progesterone LIA assay

Device Story

Luminescence immunoassay (LIA) for quantitative measurement of free progesterone in saliva; utilizes competitive binding principle. Saliva sample and enzyme-labeled antigen compete for antibody binding sites on coated wells; intensity of luminescence measured after substrate addition is inversely proportional to progesterone concentration. Results determined via standard curve. Used in clinical laboratory settings. Provides hormone levels to assist clinicians in diagnosing ovarian disorders and confirming ovulation.

Clinical Evidence

Performance established via study of 27 premenopausal women, 6 postmenopausal women, and 49 males. Comparison study of 97 healthy adult saliva samples against a modified RIA procedure yielded a correlation of r2 = 0.94 and regression formula Y=0.89*RIA + 25.5 pg/mL. Analytical metrics include intra-assay CV (0.7-6.0%) and inter-assay CV (3.4-18.8%).

Technological Characteristics

Luminescence immunoassay; competition principle. Components: rabbit anti-mouse antibody-coated microtiter plate, mouse anti-progesterone antibody, alkaline phosphatase conjugate, acridan-based chemiluminescence substrate. Specimen: saliva. Quantitative measurement via luminescence intensity. No specific energy source or connectivity described.

Indications for Use

Indicated for the quantitative measurement of active free progesterone in saliva to aid in the diagnosis and treatment of ovarian disorders and confirmation of ovulation in females.

Regulatory Classification

Identification

A progesterone test system is a device intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.

Submission Summary (Full Text)

{0}------------------------------------------------

JUL 22 2004

### SUMMARY OF

### SAFETY AND EFFECTIVENESS FOR IBL PROGESTERONE LIA

Manufacturer: IBL Immuno Biological Laboratories Flughafenstrasse 52A, D-22335 Hamburg Germany

Contact Information: Lehnus & Associates Gary Lehnus 150 Cherry Lane Rd. East Stroudsburg, PA 18301 Tel: [phone]

### Device Name / Classification:

The device trade name is the IBL Progesterone LIA having FDA assigned name: Progesterone test system, 21 CFR, 862.1620, categorized as Class I "exempt" medical devices for the Clinical Chemistry and Clinical Toxicology Panel, as Product Code JLS.

#### Device Description:

Luminescence immunoassay (LIA) based on the competition principle. An unknown amount of antigen present in the sample and a fixed amount of enzyme labeled antigen compete for the binding sites of the antibodies coated onto the wells. After incubation the wells are washed to stop the competition reaction. After addition of the luminescence substrate solution the intensity of the luminescence measured is inversely proportional to the amount of the antigen in the sample. Results of samples can be determined directly using the standard curve.

#### Device Intended Use:

Luminescence immunoassay for the in vitro diagnostic quantitative measurement of active free progesterone (a female hormone) in saliva. Measurements obtained by this device may be used in the diagnosis and treatment of disorders of the ovaries and can be used as an aid for confirmation of ovulation.

### Device Performance:

Studies were performed to establish levels of progesterone throughout the menstrual cvcles of pre-menopausal women. Saliva samples were collected from apparently healthy females known to be pre-menopausal and using no contraceptives. Three saliva samples were collected per day and pooled and frozen prior to running the Progesterone LIA assay. Collection began at the last day of bleeding and continued daily until first day of bleeding. A total of 27 premenopausal women, six postmenopausal women and 49 males were evaluated for the studies.

Comparison studies were performed using saliva samples from 97 adult healthy populations. These samples were tested with the IBL Progesterone LIA and compared to a published procedure that used a modification in the handling of saliva for a typical RIA test. Results from measuring the saliva samples in both methods yielded a correlation of r2 = 0.94 with a regression formula of Y=0.89*RIA + 25.5 pg/mL.

{1}------------------------------------------------

| Analytical Specificity<br>(Cross Reactivity) | Substance | % Cross-reactivity | | |
|----------------------------------------------|------------------------------------------------|--------------------|-----------------------------------------------------------|-----------------------|
| | 17α-Hydroxyprogesteron | 1.84 | | |
| | 6α-Methyl-<br>17α-Hydroxyprogesteron | 1.41 | | |
| | Pregnenolone | 0.41 | Cross-reactivity of<br>other substances<br>tested ≤ 0.1 % | |
| | Deoxycorticosterone | 0.28 | | |
| | Androsterone Sulfat | 0.25 | | |
| | Androstenedion | 0.20 | | |
| | Androsterone | 0.20 | | |
| | DHEA-S | 0.11 | | |
| | Corticosterone | 0.06 | | |
| | Analytical Sensitivity<br>(Limit of Detection) | 2.6 pg/mL | Mean signal (Zero-Standard) - 2SD | |
| Precision | Range (pg/mL) | CV (%) | | |
| Intra-Assay (10) | 11.5 - 822 | 6.0 - 0.7 | | |
| Inter-Assay (10) | 10.6 - 817.1 | 18.8 - 3.4 | | |
| Linearity | Range (pg/mL) | Range (%) | Mean (%) | Serial dilution up to |
| | 7.5 - 779 | 78 - 120 | 97 | 1 : 32 |
| Recovery | Range (pg/mL) | Range (%) | Mean (%) | |
| | 27 - 1497 | 82 - 121 | 103 | |

# The overall performance of the IBL Progesterone LIA is shown below:

ﺑﺮﻧﺎﻣ

| Normal ranges | Progesterone (pg/mL) | |
|---------------|------------------------------------------|---------------------------------------------------------------------------------|
| ♀ | Premenopausal<br>(n = 27 month profiles) | Follicular phase<br>28 - 82 pg/mL<br>Luteal phase<br>(peak max) 127 - 446 pg/mL |
| ♀ | Postmenopausal, n = 6 | 18 - 51 pg/mL |
| ♂ | n = 49 | < 59 pg/mL |

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with three wavy lines representing the branches of government.

JUL 22 2004

Food and Drug Administration 2098 Gaither Road

Public Health Service

Rockville MD 20850

IBL-Hamburg c/o Mr. Gary Lehnus Lehnus & Associates Consulting 150 Cherry Lane Rd. East Stroudsburg, PA 18301

k040923 Re:

Trade/Device Name: IBL Progesterone LIA Test Regulation Number: 21 CFR 862.1620 Regulation Name: Progesterone test system Regulatory Class: Class I Product Code: JLS Dated: June 10 2004 Received: June 17, 2004

Dear Mr. Lehnus:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the energy of 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 r ou may a we se provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

{3}------------------------------------------------

### Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

feain M. Cooper, US, DVM.

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known): K040923

Device Name: ____IBL_Progesterone LIA Test

### Indications For Use:

Luminescence immunoassay for the in vitro diagnostic quantitative measurement of Editinoooonoo inimanoad and hormone) in saliva. Measurements obtained by this device may be used in the diagnosis and treatment of disorders of the ovaries and can be used as an aid for confirmation of ovulation.

The IBL SaliCap Set is used for the collection, handling, and storage of saliva used in the Progesterone LIA assay.

Prescription Use __X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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

## Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic

510(k)

Office of In Vitro Diagnostic
Device Evaluation and Safety

Page 1 of ____________________________________________________________________________________________________________________________________________________________________