(25 days)
The IMMULITE/IMMULITE 1000 Total Testosterone is for in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - for the quantitative measurement of testosterone in serum and plasma, as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.
The IMMULITE 2000 Total Testosterone is for in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of total testosterone in serum and plasma, as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.
IMMULITE/IMMULITE 1000 Total Testosterone is a solid-phase, two-site competitive chemiluminescent immunoassay for use with the IMMULITE and IMMULITE 1000 Analyzers.
IMMULITE 2000 Total Testosterone is a solid-phase, two-site competitive chemiluminescent immunoassay for use with the IMMULITE 2000 Analyzer.
The provided text describes diagnostic devices for measuring testosterone, but it does not contain information about acceptance criteria or specific studies demonstrating how the device meets such criteria.
The document is a 510(k) summary for the IMMULITE®/IMMULITE® 1000 Total Testosterone and IMMULITE® 2000 Total Testosterone devices, aiming to demonstrate substantial equivalence to previously cleared predicate devices. While it describes the technology (solid-phase, competitive chemiluminescent immunoassay) and intended use, it does not include performance data, clinical study results, or specific acceptance criteria for precision, accuracy, sensitivity, or other performance characteristics that would typically be part of a study proving a device meets acceptance criteria.
The "Conclusion" section explicitly states: "The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence for IMMULITE/IMMULITE 1000 Total Testosterone and IMMULITE 2000 Total Testosterone." This implies that the full data set, which would include performance studies and their results against acceptance criteria, was submitted to the FDA separately and is not part of this public 510(k) Summary.
Therefore, I cannot provide the requested information from the provided text.
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OCT 1 0 2003
032881
510(k) Summary of Safety and Effectiveness
This summary of safety and effectiveness information has been prepared in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.
| Name:Address: | Diagnostic Products Corporation5700 West 96th StreetLos Angeles, California 90045-5597 |
|---|---|
| Telephone Number:Facsimile Number: | (310) 645-8200(310) 645-9999 |
| Contact Person: | Edward M. Levine, Ph.D.Director, Clinical Affairs |
| Date of Preparation: | September 9, 2003 |
| Device Name:Trade: | IMMULITE®/IMMULITE® 1000 Total TestosteroneIMMULITE® 2000 Total Testosterone |
| Catalog Number: | LKTW1 (100 tests), LKTW5 (500 tests)L2KTW2 (200 tests), L2KTW6 (600 tests) |
| CFR: | A testosterone test system is a device intended to measuretestosterone (a male sex hormone) in serum, plasma, andurine. Measurements of testosterone are used in thediagnosis and treatment of disorders involving the male sexhormones (androgens), including primary and secondaryhypogonadism, delayed or precocious puberty, impotencein males and, in females hirsutism (excessive hair) andvirilization (masculinization) due to tumors, polycysticovaries, and adrenogenital syndromes. |
| Common: | Reagent system for the determination of testosterone inserum and plasma. |
| Classification: | Class I device, CDZ (21CFR 862.1680) |
| Panel: | Clinical Chemistry |
| CLIA ComplexityCategory: | We believe the category to be moderate, based on previousclassification of analogous tests. |
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| Manufacturer: | Diagnostic Products Corporation5700 West 96th StreetLos Angeles, California 90045-5597 |
|---|---|
| Establishment RegistrationNumber: | DPC's Registration Number is 2017183 |
| SubstantiallyEquivalentPredicate Device: | IMMULITE/IMMULITE 1000 Total Testosterone(K022603)IMMULITE 2000 Total Testosterone (K955870) |
| Description of Device: | IMMULITE/IMMULITE 1000 Total Testosterone is a solid-phase, two-site competitive chemiluminescentimmunoassay for use with the IMMULITE andIMMULITE 1000 Analyzers. |
| IMMULITE 2000 Total Testosterone is a solid-phase, two-site competitive chemiluminescent immunoassay for usewith the IMMULITE 2000 Analyzer. |
Intended Use of the Device:
IMMULITE/IMMULITE 1000 Total Testosterone: For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - for the quantitative measurement of testosterone in serum and plasma, as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.
IMMULITE 2000 Total Testosterone: For in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of total testosterone in serum and plasma, as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.
Technology:
IMMULITE/IMMULITE 1000 Total Testosterone is a solid-phase, enzyme-labeled, competitive chemiluminescent immunoassay. The solid-phase, a polystyrene bead enclosed within an IMMULITE Test Unit, is coated with a polyclonal rabbit antibody specific for testosterone.
The patient sample and alkaline phosphatase-labeled testosterone are simultaneously introduced into the Test Unit, and incubated for approximately 60 minutes at 37℃ with intermittent agitation. During this time, testosterone in the sample competes with alkaline phosphataselabeled testosterone for antibody-binding sites on the bead. Unbound material is then removed by a centrifugal wash. Substrate is then added, and the Test Unit is incubated for a further 10 minutes.
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The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex - and thus also the photon output, as measured by the luminometer - is inversely proportional to the concentration of testosterone in the sample.
IMMULITE 2000 Total Testosterone is a solid-phase, enzyme-labeled, competitive chemiluminescent immunoasay. The solid-phase, a polystyrene bead is coated with a polyclonal rabbit antibody specific for testosterone.
The patient sample and alkaline phosphatase-labeled testosterone are simultaneously introduced into the Reaction Tube, containing the coated bead, and incubated for approximately 60 minutes at 37°C with intermittent agitation. During this time, testosterone in the sample competes with alkaline phosphatase-labeled testosterone for antibody-binding sites on the bead. Unbound material is then removed by a centrifugal wash. Substrate is then added, and the Reaction Tube is incubated for a further 5 minutes.
The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex - and thus also the photon output, as measured by the luminometer - is inversely proportional to the concentration of testosterone in the sample.
Conclusion:
The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence for IMMULITE/IMMULITE 1000 Total Testosterone and IMMULITE 2000 Total Testosterone.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three overlapping human figures or silhouettes, which are arranged in a way that suggests movement or progress. The figures are positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font.
OCT 1 0 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Edward M. Levine, Ph.D. Director, Clinical Affairs Diagnostic Products Corporation 5700 West 96th Street Los Angeles, CA 90045-5597
Re: K032881
Trade/Device Name: IMMULITE®/IMMULITE® 1000 Total Testosterone IMMULITE® 2000 Total Testosterone Regulation Number: 21 CFR 862.1680 Regulation Name: Testosterone test system Regulatory Class: Class I Product Code: CDZ Dated: September 9, 2003 Received: September 22, 2003
Dear Dr. Levine:
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.
If vour 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 Part 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).
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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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): IMMULITE®/IMMULITE® 1000 Total Testosterone Device Name: IMMULITE® 2000 Total Testosterone
Indications For Use:
The IMMULITE/IMMULITE 1000 Total Testosterone is for in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - for the quantitative measurement of testosterone in serum and plasma, as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.
The IMMULITE 2000 Total Testosterone is for in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of total testosterone in serum and plasma, as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Carol C. Benson, Jean Cooper, DVM
Division Sign-Off
e of In Vitro Diagnostic Device Evaluation and Safety
11/103288 OR Over-The-Counter Use
(Optional Format 1-2-96)
§ 862.1680 Testosterone test system.
(a)
Identification. A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.(b)
Classification. Class I.