(125 days)
Not Found
No
The description focuses on a quantitative immunoassay for sirolimus levels and does not mention any AI or ML components.
No
The device is an in vitro diagnostic assay used for quantitative analysis of sirolimus to aid in managing sirolimus therapy, not to directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section states: "The Emit® 2000 Sirolimus Assay is for the in vitro quantitative analysis of sirolimus in human whole blood as an aid in the management of sirolimus therapy in kidney transplant patients." This description clearly indicates its role in providing quantitative analysis for diagnostic purposes. Furthermore, the "Device Description" explicitly states, "The Emit® 2000 Sirolimus Assay is for in vitro diagnostic use..."
No
The device description clearly outlines physical components including antibody reagent, buffer reagent, enzyme reagent, and sample pretreatment reagent, which are chemical substances used in an in vitro diagnostic assay. It also mentions calibrators which are frozen materials. These are not software components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Emit® 2000 Sirolimus Assay is "for the in vitro quantitative analysis of sirolimus in human whole blood". The term "in vitro" is a key indicator of an IVD, meaning it's used outside of a living organism, typically in a lab setting.
- Device Description: The "Device Description" also reiterates that the assay is "for in vitro diagnostic use".
- Purpose: The assay is used to measure a substance (sirolimus) in a human sample (whole blood) to aid in the management of a medical condition (sirolimus therapy in kidney transplant patients). This is a typical function of an IVD.
- Accessory Reagents and Calibrators: The description of the accessory reagent and calibrators further supports its use as an IVD, as these are common components of diagnostic test kits.
- Predicate Devices: The mention of predicate devices (K042411 Abbott IMx® Sirolimus Assay and Calibrator) which are also IVDs, indicates that this device is intended for a similar diagnostic purpose.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Emit® 2000 Sirolimus Assay is for the in vitro quantitative analysis of sirolimus in human whole blood as an aid in the management of sirolimus therapy in kidney transplant patients.
The Emit® 2000 Siro/Tacro Sample Pretreatment Reagent is an accessory reagent for use with the Emit® 2000 Sirolimus Assay and/or the Emit® 2000 Tacrolimus Assay.
The Emit® 2000 Sirolimus Calibrators are intended for use in the calibration of the Emit® 2000 Sirolimus Assay.
Product codes (comma separated list FDA assigned to the subject device)
NRP, DLJ
Device Description
The Emit® 2000 Sirolimus Assay is for in vitro diagnostic use for the quantitative analysis of sirolimus in human whole blood as an aid in the management of sirolimus therapy in kidney transplant patients. The Emit® 2000 Sirolimus Assay is comprised of an antibody reagent, a buffer reagent and an enzyme reagent. This assay contains mouse monoclonal antibodies with a high specificity for sirolimus.
The Emit® 2000 Siro/Tacro Sample Pretreatment Reagent is an accessory reagent for use with the Emit® 2000 Sirolimus Assay. The Emit® 2000 Siro/Tacro Sample Pretreatment Reagent is used to pretreat the whole blood samples, calibrators, and controls prior to testing with the Emit® 2000 Sirolimus Assay. The pretreatment process lyses the cells, extracts the sirolimus, and precipitates most of the blood proteins. The pretreated samples are centrifuged, and an aliquot of the resulting supernatant containing sirolimus is then assayed using the Emit® 200us Assay.
The Emit® 2000 Sirolimus Calibrators are frozen material containing sirolimus in preserved whole blood hemolysate. There are six (6) calibrator levels containing 0, 3, 6, 12, 24 and 36 ng/mL.
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)
Method comparison studies were conducted at two external sites comparing the Emit® 2000 Sirolimus Assay against LC/MS/MS. Samples from kidney transplant patients were used in the studies. The mean time since transplant was 6.9 years. The data from both sites were pooled, analyzed by linear regression and resulted in the following regression statistics.
Comparator: LC/MS/MS
Slope, ng/mL: 1.30
Intercept: 0.054
r: 0.946
n: 128
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Abbott IMx® Sirolimus Assay, K042411, Abbott IMx® Sirolimus Calibrator, K042411
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
§ 862.3840 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
MAR 3 0 2009
510(k) Summary of Safety and Effectiveness Emit® 2000 Sirolimus Assay Emit® 2000 Siro / Tacro Sample Pretreatment Reagent Emit® 2000 Sirolimus Calibrator
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: K083487
1. Submitter's Contact Information and Date of Preparation
Submitter's Contact Information:
Ms. Yuk-Ting Lewis Siemens Healthcare Diagnostics Inc. P.O. Box 6101, M/S 514 Newark, DE 19714 Attn: Yuk-Ting Lewis Tel: 302-631-7626
Date of Preparation:
Nov. 24, 2008
2. Proprietary Device Name / FDA Classification Name
Emit® 2000 Sirolimus Assay / Sirolimus Test System, 21 CFR 862.3840 Emit® 2000 Siro/Tacro Sample Pretreatment Reagent, 21 CFR 862.3840 Emit® 2000 Sirolimus Calibrator / Clinical Toxicology Calibrator, 21 CFR 862.3200
3. Identification of the Predicate Device
Abbott IMx® Sirolimus Assay, K042411 Abbott IMx® Sirolimus Calibrator, K042411
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4. Device Description
The Emit® 2000 Sirolimus Assay is for in vitro diagnostic use for the quantitative analysis of sirolimus in human whole blood as an aid in the management of sirolimus therapy in kidney transplant patients. The Emit® 2000 Sirolimus Assay is comprised of an antibody reagent, a buffer reagent and an enzyme reagent. This assay contains mouse monoclonal antibodies with a high specificity for sirolimus.
The Emit® 2000 Siro/Tacro Sample Pretreatment Reagent is an accessory reagent for use with the Emit® 2000 Sirolimus Assay. The Emit® 2000 Siro/Tacro Sample Pretreatment Reagent is used to pretreat the whole blood samples, calibrators, and controls prior to testing with the Emit® 2000 Sirolimus Assay. The pretreatment process lyses the cells, extracts the sirolimus, and precipitates most of the blood proteins. The pretreated samples are centrifuged, and an aliquot of the resulting supernatant containing sirolimus is then assayed using the Emit® 2000 Sirolimus Assay.
The Emit® 2000 Sirolimus Calibrators are frozen material containing sirolimus in preserved whole blood hemolysate. There are six (6) calibrator levels containing 0, 3, 6, 12, 24 and 36 ng/mL.
5. Device Intended Use
The Emit® 2000 Sirolimus Assay is for the in vitro quantitative analysis of sirolimus in human whole blood as an aid in the management of sirolimus therapy in kidney transplant patients.
The Emit® 2000 Siro/Tac Sample Pretreatment Reagent is an accessory reagent for use with the Emit® 2000 Sirolimus Assay and/or the Emit® 2000 Tacrolimus Assay.
The Emit® 2000 Sirolimus Calibrators are intended for use in the calibration of the Emit® 2000 Sirolimus Assay.
Medical device to which equivalence is claimed and comparison information 6.
The Emit® 2000 Sirolimus Assay is substantially equivalent in intended use and technological characteristics to the Abbott IMx® Sirolimus Assay. Both devices are immunoassays intended for use in the quantitative measurement of sirolimus in human whole blood. Both devices require a manual pretreatment. The Emit® 2000 Sirolimus Assay has an assay range of 3-30 ng/mL. The Abbott IMx Sirolimus Assay has an assay range of 0-30 ng/mL.
2
Comparison Information
Method comparison studies were conducted at two external sites comparing the Emit® 2000 Sirolimus Assay against LC/MS/MS. Samples from kidney transplant patients were used in the studies. The mean time since transplant was 6.9 years. The data from both sites were pooled, analyzed by linear regression and resulted in the following regression statistics.
| Comparator | Slope, ng/mL | Intercept | r | n |
|---|---|---|---|---|
| LC/MS/MS | 1.30 | 0.054 | 0.946 | 128 |
7. Conclusion
Based on a review of the devices technological features and the method comparison study, the Emit® 2000 Sirolimus Assay, Siro/Tacro Sample Pretreatment Reagent and Sirolimus Calibrators are substantially equivalent to the legally marked devices, the Abbott IMx® Sirolimus Assay and Sirolimus Calibrator.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a caduceus, a symbol often associated with healthcare, alongside the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the emblem. The caduceus is rendered in black, and the text is also in black, set against a white background.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Siemens Healthcare Diagnostics Inc. c/o Yuk-Ting Lewis P.O. Box 6101, M/S 514 Newark, DE 19714
MAR 3 0 2009
Re: K083487
Trade name: EMIT 2000 Sirolimus Assay Regulation Number: 21 CFR 862.3840 Regulation Name: Sirolimus Test System Regulatory Class: Class II Product Code: NRP, DLJ Dated: February 26, 2009 Received: February 27, 2009
Dear Ms Lewis:
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 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 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).
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.
ﻳﺔ ﺍﻟ ::
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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.
Corg C. He
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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Indication for Use
510(k) Number (if known):
Emit® 2000 Sirolimus Assay Device Name: Emit® 2000 Siro/Tacro Sample Pretreatment Reagent Emit® 2000 Sirolimus Calibrator
Indications For Use:
The Emit® 2000 Sirolimus Assay is for the in vitro quantitative analysis of sirolimus in human whole blood as an aid in the management of sirolimus therapy in kidney transplant patients.
The Emit® 2000 Siro/Tacro Sample Pretreatment Reagent is an accessory reagent for use with the Emit® 2000 Sirolimus Assay and/or the Emit® 2000 Tacrolimus Assay.
The Emit® 2000 Sirolimus Calibrators are intended for use in the calibration of the Emit® 2000 Sirolimus Assay.
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 Diagnostic Device Evaluation and Safety (OIVD)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K083487
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