(117 days)
No
The description focuses on automated sample handling, processing, and communication between instruments, which are standard laboratory automation functions and do not indicate the use of AI or ML.
No.
This device is an in vitro diagnostic (IVD) system used to measure analytes in body fluids, which aids in diagnosis and treatment, rather than directly providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany." Additionally, the "Device Description" states that the system is "designed to perform in vitro diagnostic testing on clinical specimens."
No
The device description clearly outlines a physical instrument (Dimension® RxL Max® Clinical Chemistry System) and a laboratory automation system (ADVIA® Modular Automation System) with various hardware components for sample handling and processing. While software controls these systems, the device itself is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the system "measures a variety of analytes, including enzyme activities in body fluids" and specifically mentions the Calcium assay which is "intended to quantitatively measure Calcium in human serum or plasma." It also states that these measurements are "used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany." This clearly indicates the device is used to test specimens from the human body to provide information for diagnostic purposes.
- Device Description: The description of the Dimension® RxL Max® Chemistry System states it is "designed to perform in vitro diagnostic testing on clinical specimens."
- Predicate Device: The predicate devices listed are also clinical chemistry systems and reagent cartridges, which are typical IVD devices.
The entire context of the document describes a system used in a clinical laboratory setting to perform tests on human samples for medical purposes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Dimension® RxL Max® Clinical Chemistry System with Sample Transfer Module and the ADVIA® Modular Automation System is a discrete random access, microprocessorcontrolled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities in body fluids. The system menu will include assays, such as Calcium, along with other various assays that may be adaptable to the analyzer depending on the reagent used.
Calcium is intended to quantitatively measure Calcium in human serum or plasma. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
Product codes
JJE, CIC
Device Description
The Dimension® RxL Max® Chemistry System is a continuous operation chemistry analyzer designed to perform in vitro diagnostic testing on clinical specimens and is a family member of the Dimension® XL Clinical Chemistry System (traditional 510(k) filed in 1994 K944093). The Dimension® RxL Max® Chemistry System has also been cleared with StreamLab Analytical WorkCell and Sample Transfer Module (K043546)
The ADVIA® Modular Automation System (AMAS) is a laboratory automation system (LAS) designed to automate sample handling and processing in the clinical laboratory. AMAS is available as two products ADVIA® LabCell® and ADVIA® WorkCell. These LAS systems are made up of the same components and are controlled by common software. The systems differ in their expansion capabilities:
ADVIA® WorkCell is an ADVIA® Automation solution that is limited to three fixed configurations supporting up to a total of five interface stations.
ADVIA® LabCell® is customizable ADVIA® Automation solution that is configurable with up to 16 interface stations.
Dimension® RxL Max® Chemistry System (Dimension) with Sample Transfer Module and the ADVIA® Modular Automation System combines the features of both the analyzer and the laboratory automation system.
The ADVIA® Modular Automation System (AMAS) routes samples to the Dimension analyzer based on test request information received from the Laboratory Information System (LIS) and the test map established for the Dimension analyzer. AMAS and Dimension communicate sample and analyzer status via Dimension's Laboratory Automation System (LAS) interface. Via its Laboratory Information System (LIS) interface, the Dimension analyzer interfaces separately with the hospital's LIS to receive its test instructions (test requests) and to report results for each sample. Dimension's test instructions and test results for each sample are not processed through the AMAS.
AMAS performs the following pre and post-analytical functions.
- Sample bar code identification (previously performed by the Dimension) .
- Sample transport and tracking (pre-Analytical) .
- Sample centrifugation (optional functionality) .
- Sample de-capping (optional functionality) .
- Sample transport and tracking (post-Analytical) .
The Dimension continues to perform the following functions, when connected to AMAS.
- All functions except reading the sample tube bar code. When Dimension is . connected to AMAS, samples can be loaded directly onto Dimension and/or loaded onto AMAS and routed to Dimension. For samples loaded onto the AMAS, which reads the sample tube bar code (sample identification) and passes it electronically to Dimension via the LAS interface.
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)
Split-sample method comparison studies were conducted using the Dimension® RxL MAX® Calcium assay. Samples were processed either directly on the predicate device or on the proposed device. The data were analyzed by linear regression and the results are summarized in the table below.
| Method | n | r | Slope | Intercept | Syx | 95% CI Slope | 95% CI Intercept | % Mean Bias |
|---|---|---|---|---|---|---|---|---|
| Ca | 98 | 0.989 | 1.05 | -0.4 | 0.3 | 1.02 to 1.08 | -3.5 to 2.7 | -0.1 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.
0
510(k) Summary of Safety and Effectiveness Dimension® RxL Max® Chemistry System with Sample Transfer Module and the ADVIA® Modular Automation System
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: _ KO&3339
1. Submitter's Contact Information and Date of Preparation
| Submitter's Contact Information: | Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue |
|----------------------------------|------------------------------------------------------------|
| | Tarrytown, NY 10591 |
| | Attn: Lubomyr Shchur
Tel: 914 524-2091 |
| Date of Preparation: | February 27, 2000 |
Date of Preparation:
February 27, 2009
2. Proprietary Device Name / FDA Classification Name
Dimension® RxL Max® Chemistry System with Sample Transfer Module and the ADVIA® Modular Automation System (LabCell®/WorkCell) / Class I: Discrete photometric chemistry analyzer for clinical use (21CFR§862.2160), Product Code JJE
3. Identification of the Predicate Device
| Predicate Instrument or Method | 510(k) | Product Code |
|---|---|---|
| Dimension® XL Clinical | ||
| Chemistry System | K944093 | JJE |
| Dimension® CA Flex Reagent | ||
| Cartridge | K860021 | CIC |
4. Device Description(s):
The Dimension® RxL Max® Chemistry System is a continuous operation chemistry analyzer designed to perform in vitro diagnostic testing on clinical specimens and is a family member of the Dimension® XL Clinical Chemistry System (traditional 510(k) filed in 1994 K944093). The Dimension® RxL Max® Chemistry System has also been cleared with StreamLab Analytical WorkCell and Sample Transfer Module (K043546)
The ADVIA® Modular Automation System (AMAS) is a laboratory automation system (LAS) designed to automate sample handling and processing in the clinical laboratory. AMAS is available as two products ADVIA® LabCell® and ADVIA® WorkCell. These
1
LAS systems are made up of the same components and are controlled by common software. The systems differ in their expansion capabilities:
ADVIA® WorkCell is an ADVIA® Automation solution that is limited to three fixed configurations supporting up to a total of five interface stations.
ADVIA® LabCell® is customizable ADVIA® Automation solution that is configurable with up to 16 interface stations.
Dimension® RxL Max® Chemistry System (Dimension) with Sample Transfer Module and the ADVIA® Modular Automation System combines the features of both the analyzer and the laboratory automation system.
The ADVIA® Modular Automation System (AMAS) routes samples to the Dimension analyzer based on test request information received from the Laboratory Information System (LIS) and the test map established for the Dimension analyzer. AMAS and Dimension communicate sample and analyzer status via Dimension's Laboratory Automation System (LAS) interface. Via its Laboratory Information System (LIS) interface, the Dimension analyzer interfaces separately with the hospital's LIS to receive its test instructions (test requests) and to report results for each sample. Dimension's test instructions and test results for each sample are not processed through the AMAS.
AMAS performs the following pre and post-analytical functions.
- Sample bar code identification (previously performed by the Dimension) .
- Sample transport and tracking (pre-Analytical) .
- Sample centrifugation (optional functionality) .
- Sample de-capping (optional functionality) .
- Sample transport and tracking (post-Analytical) .
The Dimension continues to perform the following functions, when connected to AMAS.
- All functions except reading the sample tube bar code. When Dimension is . connected to AMAS, samples can be loaded directly onto Dimension and/or loaded onto AMAS and routed to Dimension. For samples loaded onto the AMAS, which reads the sample tube bar code (sample identification) and passes it electronically to Dimension via the LAS interface.
5. Device Intended Use:
The Dimension® RxL Max® Clinical Chemistry System with Sample Transfer Module and the ADVIA® Modular Automation System is a discrete random access, microprocessor controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities in body fluids. The system menu will include assays, such as Calcium, along with other various assays that may be adaptable to the analyzer depending on the reagent used.
Calcium is intended to quantitatively measure Calcium in human serum or plasma. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
2
Medical device to which equivalence is claimed 6.
Dimension® RxL Max® Clinical Chemistry System is a family member of the Dimension® XL Clinical Chemistry System (traditional 510(k) filed in 1994 K944093). The devices have same / similar design and modes of operation. The key features are summarized in the following table.
| Feature | Predicate Device:
Dimension® RxL Max® | Proposed Device:
Dimension® RxL Max® with
ADVIA® Modular Automation
System (AMAS) |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Dimension® RxL Max® clinical chemistry system is a discrete, random-access, microprocessor-controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities in body fluids. | The Dimension® RxL Max® Clinical Chemistry System with Sample Transfer Module and the ADVIA® Modular Automation System is a discrete random access, microprocessor controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities in body fluids. The system menu will include assays, such as Calcium, along with other various assays that may be adaptable to the analyzer depending on the reagent used. |
| Methodology | Analyzer, chemistry (photometric, discrete), for clinical use has been classified as Class I, JJE by the Clinical Chemistry and Clinical Toxicology Devices Panel, (21 CFR 862.2160). No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act. | Analyzer, chemistry (photometric, discrete), for clinical use has been classified as Class I, JJE by the Clinical Chemistry and Clinical Toxicology Devices Panel, (21 CFR 862.2160). No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act. |
| Sample Loading | Load directly onto the Dimension | Load directly onto the Dimension and/or onto AMAS |
| Sample Types | Serum, Plasma, Cerebral Spinal Fluid, Urine and Whole Blood | Serum, Plasma, Cerebral Spinal Fluid, and Urine |
Device Description and Comparison
3
| Feature | Predicate Device:
Dimension® RxL Max® | Proposed Device:
Dimension® RxL Max® with
ADVIA® Modular Automation
System (AMAS) |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Serum and
Plasma Sample
Preparation | Manually centrifuged samples.
Manually de-capped sample tubes | Manually centrifuged samples or
automatically centrifuged by AMAS.
Manually de-capped sample tubes or
automatically de-capped tubes by
AMAS |
| Sample
Identification of
Bar-Coded
Tubes | Tube bar code (identification) is read
by the analyzer. | Tube bar code (identification) is read
by the Dimension (when tubes are
placed
directly on the Dimension);
or
Tube bar code read by AMAS and
communicated electronically to the
Dimension (when tubes are loaded
onto AMAS). |
| Test Orders | Unidirectional communication with external LIS | |
| Test Results | Unidirectional communication with external LIS | |
| Laboratory
Automation | Dimension's software communicates with Lab Automation System via LAS
interface. Dimension's Sample Transfer Module performs direct sampling
from tube on the track. | |
Method Comparison
Split-sample method comparison studies were conducted using the Dimension® RxL MAX® Calcium assay. Samples were processed either directly on the predicate device or on the proposed device. The data were analyzed by linear regression and the results are summarized in the table below.
| Method | n | r | Slope | Intercept | Syx | 95% CI Slope | 95% CI Intercept | % Mean Bias |
|---|---|---|---|---|---|---|---|---|
| Ca | 98 | 0.989 | 1.05 | -0.4 | 0.3 | 1.02 to 1.08 | -3.5 to 2.7 | -0.1 |
7. Conclusion:
The proposed Dimension® RxL MAX® with ADVIA® Modular Automation System and the predicate Dimension® RxL Max® (K043546) are substantially equivalent in design, modes of operation, assay performance and intended use.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Siemens Healthcare Diagnostics Inc. c/o Mr. Lubomyr Shchur. Regulatory Affairs and Compliance Specialist 511 Benedict Avenue Tarrytown, New York 10591-5097
Re: K083339
Trade/Device Name: Dimension® RxL Max® Clinical Chemistry System with Sample Transfer Module and the ADVIA® Modular Automation System (LabCell®/WorkCell) with Calcium Reagents
MAR
9 2009
Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium test system Regulatory Class: Class II Product Code: CIC, JJE Dated: February 9, 2009 Received: February 10, 2009
Dear Mr. Shchur:
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); Iabeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
5
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 (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 vours.
Coy C. Hh
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
6
Indication for Use
510(k) Number (if known): K083339
Device Name:
Dimension® RxL Max® Clinical Chemistry System with Sample Transfer Module and the ADVIA® Modular Automation System (LabCell® / WorkCell) with Calcium Reagents
Indication for Use:
The Dimension® RxL Max® Clinical Chemistry System with Sample Transfer Module and the ADVIA® Modular Automation System is a discrete random access, microprocessorcontrolled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities in body fluids. The system menu will include assays, such as Calcium, along with other various assays that may be adaptable to the analyzer depending on the reagent used.
Calcium is intended to quantitatively measure Calcium in human serum or plasma. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
Prescription Use
(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)
Ruth Wheeler
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K083339