(28 days)
For in vitro diagnostic use with the IMMULITE 2000 Analyzer – for the quantitative measurement of gentamicin in serum or plasma, as an aid in monitoring the therapeutic administration of this aminoglycoside.
IMMULITE® 2000 Gentamicin is a solid-phase chemiluminescent enzyme immunoassay for use with the IMMULITE® 2000 Automated Analyzer.
Acceptance Criteria and Study for IMMULITE® 2000 Gentamicin
The IMMULITE® 2000 Gentamicin device's performance was evaluated by comparing it to a predicate device, the Abbott AxSYM® Gentamicin. The acceptance criteria essentially revolved around demonstrating substantial equivalence in measuring gentamicin concentrations in human specimens.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied by Comparison) | Reported Device Performance (IMMULITE® 2000 vs. Abbott AxSYM® Gentamicin) |
|---|---|---|
| Correlation | Strong linear correlation (e.g., r > 0.95) | r = 0.973 |
| Linearity | Close agreement in slope and intercept | (IMMULITE 2000) = 0.94 (Abbott AxSYM® Gentamicin) + 0.2 µg/mL |
| Bias | Minimal difference in mean concentrations | Means: 3.0 µg/mL (IMMULITE 2000) vs. 2.9 µg/mL (Abott AxSYM®) |
| Range Tested | Clinically relevant concentration range | 0.5 to 8.0 µg/mL |
Note: The document does not explicitly state pre-defined quantitative acceptance criteria. The "Acceptance Criteria (Implied by Comparison)" are inferred from the typical standards for demonstrating substantial equivalence against a predicate device in method comparison studies.
2. Sample Size and Data Provenance for the Test Set
- Sample Size: 89 patient samples.
- Data Provenance: Not explicitly stated, but based on the nature of the device (in vitro diagnostic for monitoring drug levels in human specimens), it is prospective, collected from patients. The country of origin is not specified, but the manufacturer is based in the USA.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable. The ground truth for the test set was established by the predicate device (Abbott AxSYM® Gentamicin), not through expert consensus.
- Qualifications of Experts: N/A
4. Adjudication Method for the Test Set
- Adjudication Method: None. The comparison was directly between the IMMULITE® 2000 and the predicate device's measurements for each sample.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This is an in vitro diagnostic device for quantitative measurement, not an imaging or diagnostic interpretation device that typically involves human readers.
6. Standalone Performance Study
- Standalone Performance Study: Yes, in the sense that the IMMULITE® 2000 Gentamicin's measurements were observed independently. However, its performance was evaluated and understood in the context of comparison to the predicate device. The results (linear regression, correlation coefficient, means) represent the standalone performance relative to a reference.
7. Type of Ground Truth Used
- Type of Ground Truth: Measurements from a legally marketed and accepted predicate device (Abbott AxSYM® Gentamicin).
8. Sample Size for the Training Set
- Sample Size for Training Set: The document does not explicitly mention a separate "training set" in the context of an AI/machine learning model. The IMMULITE® 2000 Gentamicin is a chemiluminescent immunoassay, a chemical assay, not an AI-powered algorithm that requires a training set in the typical sense. Its calibration would rely on reference standards rather than a "training set" of patient data.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. As mentioned above, this is a chemical immunoassay, not an AI algorithm. Calibration and quality control for such assays typically involve known concentrations of gentamicin standards, which serve as the reference for accurate measurement.
{0}------------------------------------------------
510 (k) Summary Safety and Effectiveness
This summary of safety and effectiveness information has been prepared in accordance I his sammary of safety and offer and 21 CFR Part 807.92.
| Name: | Diagnostic Products Corporation |
|---|---|
| Address: | 5700 West 96th StreetLos Angeles, CA 90045 |
| Telephone Number: | (310) 645-8200 |
| Facsimile Number: | (310) 645-9999 |
| Contact Person: | Edward M. Levine, Ph.D.Director of Clinical Affairs |
| Date of Preparation: | July 20, 2001 |
| Device Name:Trade: | IMMULITE® 2000 Gentamicin |
| Catalog Number: | L2KGE2 (200 tests), L2KGE6 (600 tests) |
| CFR: | A gentamicin test system is a device intended to measuregentamicin, an antibiotic drug, in human specimens.Measurements obtained by this device are used in thediagnosis and treatment of gentamicin overdose and inmonitoring levels of gentamicin to ensure appropriatetherapy. |
| Common: | Reagent system for the determination of gentamicin inplasma and serum. |
| Classification: | Class II device, LCD (21 CFR 862.3450) |
| Panel: | Toxicology |
| CLIA ComplexityCategory: | We believe the category to be moderate, based on previousclassification of analogous tests. |
{1}------------------------------------------------
| Manufacturer: | Diagnostic Products Corporation (DPC)5700 West 96th StreetLos Angeles, CA 90045-5597 | |
|---|---|---|
| EstablishmentRegistration #: | DPC's establishment Registration No. is 2017183 | |
| Substantially EquivalentPredicate Device: | Abbott AxSYM® Gentamicin (K935376) | |
| Description of Device: | IMMULITE® 2000 Gentamicin is a solid-phasechemiluminescent enzyme immunoassay for use with theIMMULITE® 2000 Automated Analyzer. | |
| Intended Use of theDevice: | IMMULITE® 2000 Gentamicin is for in vitro diagnosticuse with the IMMULITE 2000 Analyzer - for thequantitative measurement of gentamicin in serum orplasma, as an aid in monitoring the therapeuticadministration of this aminoglycoside. |
Technology:
This section does not contain any new information for a reviewer who is familiar with the This section actor not of the review of previous IMMULITE® 2000 assay submissions.
IMMULITE 2000 Gentamicin is a solid-phase, chemiluminescent competitive immunoassay. The solid-phase, a polystyrene bead, is coated with a polyclonal rabbit antibody specific for gentamicin.
The patient sample and a buffer matrix are introduced into the sample pretreatment cup The patient banks at 37℃. The diluted sample is then transferred with alle medoled for over of the Reaction Tube containing a gentaining a gentamicin antibody-coated bead and incubated for another 30-minutes cycle at 37℃ with intermittent agitation. During this time, gentamicin in the samples competes with mermeetin againsmicin for a limited number of antibody binding sites on the bead. eneyme facered gentrificate is then removed by a centrifugal wash, after which substrate is added and the Reaction Tube is incubated for an additional 5 minutes
{2}------------------------------------------------
The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The nyarely aroduction 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 gentamicin in the sample.
Abbott AxSYM Gentamicin utilizes fluorescence polarization immunoassay technology in a competitive ligand format. The unlabeled antibiotic (antigen being measured) competes with the fluorescent-labeled antigen for the antibody binding sites. With increasing concentration of unlabeled antigen, more fluorescent-labeled antigen becomes unbound. Therefore, the fluorescent polarization signal decreases as the drug concentration increases, as measured by the fluorometer. Concentrations are determined from a stored standard curve.
Performance Equivalence:
Diagnostic Products Corporation asserts that the IMMULITE 2000 Gentamicin produces substantially equivalent results to other commercially marketed gentamicin assays, such as Abbott AxSYM® Gentamicin. The assay, Abbott AxSYM® Gentamicin utilizes fluorescence polarization technology. Each product is designed for the quantitative measurement of gentamicin in serum or plasma. Each product is intended strictly for in vitro diagnostic use as an aid in monitoring the therapeutic administration of this drug.
Method Comparison:
The IMMULITE 2000 Gentamicin procedure was compared to a commercially available gentamicin assay (Abbott AxSYM® Gentamicin) on 89 patient samples, with gentamicin concentrations ranging from approximately 0.5 to 8.0 µg/mL. Linear regression analysis yielded the following statistics.
(IMMULITE 2000) = 0.94 (Abbott AxSYM® Gentamicin) + 0.2 µg/mL
r = 0.973
| Means: | 3.0 µg/mL (IMMULITE 2000) |
|---|---|
| 2.9 µg/mL (Abbott AxSYM®) |
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® 2000 Gentamicin
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three overlapping lines that resemble an abstract representation of a human form or a symbol of interconnectedness.
AUG 2 0 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Edward M. Levine, Ph.D. Director of Clinical Affairs Diagnostic Products Corporation 5700 West 96th Street Los Angeles, CA 90045-5597
510(k) Number: K012311 Re: Trade/Device Name: IMMULITE®2000 Gentamicin Regulation Number: 862.3450 Regulatory Class: II Product Code: LCD Dated: July 20, 2001 Received: July 23, 2001
Dear Dr. Levine:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have lovice your boomes be device is substantially equivalent to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include the goneral of 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remancer ripps of any was found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such perious ons. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{4}------------------------------------------------
Page 2 -
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
510(k) Number (if known): HO1231 Device Name: IMMULITE®2000 Gentamicin
Indications For Use:
For in vitro diagnostic use with the IMMULITE 2000 Analyzer – for the quantitative measurement of gentamicin in serum or plasma, as an aid in monitoring the therapeutic administration of this aminoglycoside.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kesia Alexander San Juan Corpos
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K012311
Prescription Us (Per 21 CFR 801 109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 862.3450 Gentamicin test system.
(a)
Identification. A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.(b)
Classification. Class II.