(212 days)
Not Found
No
The summary describes a standard immunoassay (MEIA) for quantitative determination of a drug. There is no mention of AI, ML, image processing, or any computational methods that would suggest the use of such technologies. The performance studies focus on analytical comparisons and assay characteristics, not on the performance of an AI/ML algorithm.
No.
This device is an in vitro diagnostic (IVD) reagent system used to measure sirolimus levels in blood, aiding in the management of renal transplant patients. It does not directly treat or restore health.
Yes
The device "provides quantitative determination of sirolimus in human whole blood as an aid in the management of renal transplant patients receiving sirolimus therapy," which indicates its use in aiding medical diagnoses or monitoring patient conditions.
No
The device description clearly outlines a Microparticle Enzyme Immunoassay (MEIA) which involves physical reagents, incubation steps, washing, and measurement of a fluorescent product. This is a laboratory-based assay requiring hardware (the Abbott IMx® system) and chemical reagents, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is an "in vitro reagent system for the quantitative determination of sirolimus in human whole blood". This clearly indicates the testing is performed outside of the body using biological samples.
- Device Description: The description details a "Microparticle Enzyme Immunoassay (MEIA)" which is a laboratory-based testing method.
- Sample Type: The assay is designed to test "human whole blood", a biological specimen.
- Purpose: The purpose is to aid in the "management of renal transplant patients receiving sirolimus therapy", which is a diagnostic or monitoring purpose.
- Components: The description lists various reagents and calibrators used in a laboratory setting for performing the test.
All of these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IMx Sirolimus assay is an in vitro reagent system for the quantitative determination of sirolimus in human whole blood as an aid in the management of renal transplant patients receiving sirolimus therapy.
The IMx® Sirolimus Calibrators are for the calibration of the IMx Analyser when used for the quantitative determination of sirolimus in human whole blood.
The IMx® Sirolimus MODE 1 Calibrator is for the adjustment of the stored calibration of the IMx Analyser when used for the quantitative determination of sirolimus in human whole blood.
The IMx® Sirolimus Controls are for the verification of the calibration of the IMx Analyser when used for the quantitative determination of sirolimus in human whole blood.
The IMx Sirolimus Whole Blood Precipitation Reagent is for the extraction of sirolimus from samples (whole blood patient specimens, IMx® Sirolimus Calibrators and Controls) to be tested on the IMx® Sirolimus assay.
An in vitro reagent system for the quantitative determination of sirolimus in human whole blood, as an aid in the management of renal transplant patients receiving sirolimus therapy.
Product codes (comma separated list FDA assigned to the subject device)
NRP, LAS, DLJ
Device Description
Competition tormal.
Microparticle Enzyme Immunoassay (MEIA) for use on Abbott IMx® system.
Assay procedure:
- Incubate the sample with the anti-sirolimus antibody-coated microparticles.
- Add sirolimus alkaline phosphatase conjugate and incubate.
- Transfer to matrix cell.
- Wash to remove unbound substances.
- Add substrate.
- Measure fluorescent product.
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
Not Found
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)
The Abbott IMx Sirolimus assay was compared to the HPLC/MS/MS method.
Clinical Site: All Samples, All Sites.
Method X: LC/MS/MS, Unit: ng/ml.
Method Y: IMx, Unit: ng/ml.
n: 221.
Min X: 2.900, Max X: 90.100.
Min Y: 3.800, Max Y: 81.900.
Passing / Bablok: B/P b 1.230, B/P a -0.250.
r: 0.956.
Disp. of Residuals: md(68) 1.057, md(95) 2.745.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision: Total imprecision of ≤ 15% through assay range of 5-22ng/ml.
Recovery: Mean recovery across samples of 90 - 110% of expected values.
Dilution Linearity: Mean recovery across samples of 99 - 115% of expected values.
Analytical Sensitivity: ≤ 1.5ng/ml.
Functional Sensitivity: ≤ 2.5ng/ml.
Specificity for Parent Compound: Cross-reactivity seen at the following levels with the metabolites studied: 11-hydroxy-sirolimus - 37%, 41-O-demethyl-sirolimus - 58%, 7-O-demethyl-sirolimus - 63%, 41-O-demethyl-hydroxyl-sirolimus - 6%.
Co-Administered Drug Interference: 62 drugs tested. Of these, the following showed between 10% and 15% apparent interference with the Medium Control: Gemfibrozil (75µg/ml) ; Itraconazole (10.5µg/ml) ; MPAG (1800µg/ml) ; OKT3(6.0µg/ml) ; Trimethoprim (40µg/ml).
Interference from Endogenous Compounds:
§ 862.3840 Sirolimus test system.
(a)
Identification. A sirolimus test system is a device intended to quantitatively determine sirolimus concentrations in whole blood. Measurements are used as an aid in management of transplant patients receiving therapy with sirolimus.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Sirolimus Test Systems.” See § 862.1(d) for the availability of this guidance document.
0
Image /page/0/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 emblem with three curved lines, resembling a human figure, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the emblem. The text is in all caps and is slightly distorted due to the circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 6 2005
Ms. Susan Leonard Regulatory Affairs Manager Axis-Shield Diagnostics Ltd. The Technology Park Dundee, Tayside, Scotland United Kingdom DD21XA
Re: K042411
Trade/Device Name: IMx® Sirolimus Microparticle Enzyme Immunoassay, IMx® Sirolimus Calibrators, IMx® Sirolimus Controls Regulation Number: 21 CFR 862.3840 Regulation Name: Sirolimus Test System Regulatory Class: Class II Product Code: NRP, LAS, DLJ
Dear Ms. Leonard:
This letter corrects our substantially equivalent letter of April 7, 2005 regarding the cleared devices and their product codes. The original letter failed to mention the clearance of your calibrators and controls.
We have reviewed your Section 510(k) premarket notification of intent to market the devices 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 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.
1
Page 2 - Ms. Susan Leonard
Please be advised that FDA's issuance of a substantial equivalence determinationdoes 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 (OS) regulation (21 CFR Part 820).
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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Albert
: Carol C. Benson, M.A.
Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
3. INDICATIONS FOR USE
510(k) Number (if known): K042411
Device Name: IMx® Sirolimus Microparticle Enzyme Immunoassay
Indications For Use: The IMx Sirolimus assay is an in vitro reagent system for the quantitative determination of sirolimus in human whole blood as an aid in the management of renal transplant patients receiving sirolimus therapy.
The IMx® Sirolimus Calibrators are for the calibration of the IMx Analyser when used for the quantitative determination of sirolimus in human whole blood.
The IMx® Sirolimus MODE 1 Calibrator is for the adjustment of the stored calibration of the IMx Analyser when used for the quantitative determination of sirolimus in human whole blood.
The IMx® Sirolimus Controls are for the verification of the calibration of the IMx Analyser when used for the quantitative determination of sirolimus in human whole blood.
The IMx Sirolimus Whole Blood Precipitation Reagent is for the extraction of sirolimus from samples (whole blood patient specimens, IMx® Sirolimus Calibrators and Controls) to be tested on the IMx® Sirolimus assay.
V Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
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)
Albert Satz'
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K042411
Page 1 of 1
3
and the same of the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of
Axis-Shield Diagnostics Ltd 26th January 2005
K042411 - IMx®Sirolimus Page 1 of 4
510(k) Summary
Introduction
The following summary is intended to support a claim for the Abbott IMx Sirolimus
Assay of substantial equivalence to the Microgenics CEDIA Sirolimus Assay
(K034069).
Submitter name, address, contact
Axis-Shield Diagnostics Ltd. The Technology Park Dundee DD2 1XA Scotland, UK Tel : +44 1382 422000 Fax: +44 1382 422088
| Contact Person: | Susan Leonard |
|---|---|
| Email address: | susan_leonard@uk.axis-shield.com |
| Date Prepared: | January 26th, 2005 |
Device Name
| Proprietary Name: | Abbott IMx® Sirolimus Microparticle Enzyme Immunoassay
(MEIA) test | | |
|----------------------|--------------------------------------------------------------------------------|-----------------|--------------------------|
| Common name: | Microparticle Enzyme Immunoassay (MEIA) for the
determination of sirolimus. | | |
| Classification name: | Sirolimus test system | | |
| Product Code : | NRP | Classification: | Class II
CFR 862.3840 |
Predicate Device
I i current Device accepted reference method for sirolimus measurement, which is High Performance Liquid Chromatography-tandem Mass Spectrometry (HPLC/MS/MS). There is also a comparison of performance characteristics for the IMx® Sirolimus Assay and the Microgenics CEDIA® Sirolimus Assay (K034069).
4
510(k) Summary
Device Description
Competition format.
Competition tormal.
Microparticle Enzyme Immunoassay (MEIA) for use on Abbott IMx® system.
Assay procedure:
-
Incubate the sample with the anti-sirolimus antibody-coated microparticles. 프
and the same of the same of the same of the same of the same and the same and the seat and the seat and the search and -
Add sirolimus alkaline phosphatase conjugate and incubate. ..
-
Transfer to matrix cell. 포
-
Wash to remove unbound substances. .
-
L Add substrate.
-
Measure fluorescent product. .
Intended Use
An in vitro reagent system for the quantitative determination of sirolimus in human whole blood, as an aid in the management of renal transplant patients receiving sirolimus therapy.
Comparison to HPLC/MS/MS Method
The Abbott IMx Sirolimus assay was compared to the HPLC/MS/MS method. The resulting Passing-Bablok correlation statistics are summarised in the following table:
| Clinical
Site | Method X | | Method Y | | n | Min X | Max X | Min Y | Max Y | Passing /
Bablok | | r | Disp. of
Residuals | |
|------------------|------------|-------|------------|-------|-----|-------|--------|-------|--------|---------------------|--------|-------|-----------------------|--------|
| | Instrument | Unit | Instrument | Unit | | | | | | B/P b | B/P a | | md(68) | md(95) |
| All Samples | | | | | | | | | | | | | | |
| All Sites | LC/MS/MS | ng/ml | IMx | ng/ml | 221 | 2.900 | 90.100 | 3.800 | 81.900 | 1.230 | -0.250 | 0.956 | 1.057 | 2.745 |
5
510(k) Summary
Performance Characteristics of Abbott IMx® Sirolimus MEIA Test vs the Microgenics CEDIA® Sirolimus Test:
| Parameter | IMx® Sirolimus MEIA Test | CEDIA® Sirolimus Test
(K034069) |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Precision | Total imprecision of ≤ 15%
through assay range of 5-22ng/ml | Within-run CV of 2.2 - 7.0%.
Between-run CV of 2.2 - 9.2%. |
| Recovery | Mean recovery across samples of
90 - 110% of expected values. | Recovery of 101 - 112% of
expected values. |
| Dilution Linearity | Mean recovery across samples of
99 - 115% of expected values. | Recovery of 91 - 106% of
expected values for a single
high sample. |
| Analytical Sensitivity | ≤ 1.5ng/ml | 4.0 ng/mL |
| Functional Sensitivity | ≤ 2.5ng/ml | Not listed. |
| Specificity for Parent
Compound | Cross-reactivity seen at the
following levels with the
metabolites studied:
11-hydroxy-sirolimus - 37%
41-O-demethyl-sirolimus - 58%
7-O-demethyl-sirolimus - 63%
41-O-demethyl-hydroxyl-
sirolimus - 6% | Cross-reactivity seen at the
following levels with the
metabolites studied:
11-hydroxy - 44%
41-O- and 32-O -Demethyl -
73%
Trihydroxy and 41-O-
didemethyl - 14%
41-desmethyl-hydroxy- 10%
Fraction 2 and 7-O-desmethyl
- 8.7%
Isomers of fraction 4 - 22%
Hydroxyl - 7%
N-oxide - 15%
Fraction 6 and isomers of
Fraction 7 - 4% |
| Parameter | IMx® Sirolimus MEIA Test | CEDIA® Sirolimus Test
(K034069) |
| Co-Administered
Drug Interference | 62 drugs tested. Of these, the
following showed between 10%
and 15% apparent interference
with the Medium Control:
Gemfibrozil (75µg/ml) ;
Itraconazole (10.5µg/ml) ;
MPAG (1800µg/ml) ;
OKT3(6.0µg/ml) ; Trimethoprim
(40µg/ml). | 42 drugs tested. These showed