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.

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.

AI/ML Overview

The document describes the Dimension® RxL Max® Chemistry System with Sample Transfer Module and the ADVIA® Modular Automation System and its substantial equivalence to a predicate device for measuring Calcium in human serum or plasma.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria in terms of specific performance thresholds for metrics like correlation coefficient, slope, intercept, or bias. Instead, it presents results of a method comparison study for the Calcium assay and aims to demonstrate substantial equivalence to the predicate device.

The study's implicit "acceptance criteria" appear to be that the performance metrics of the proposed device are within an acceptable range compared to the predicate device, as concluded by the statement of substantial equivalence.

Metric	Reported Device Performance (Calcium assay)	Implicit Acceptance/Comparison to Predicate
n	98	Sample size for method comparison
r (correlation coefficient)	0.989	Very strong correlation between methods
Slope	1.05	Close to 1.0, indicating good agreement
Intercept	-0.4	Close to 0, indicating minimal constant bias
Syx	0.3	Measure of scatter around the regression line
95% CI Slope	1.02 to 1.08	Range includes 1.0, supporting agreement
95% CI Intercept	-3.5 to 2.7	Range includes 0, supporting agreement
% Mean Bias	-0.1	Very low, indicating minimal systematic difference

Conclusion from document: "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."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: 98 samples were used for the method comparison study ("n" = 98 in the table).
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It is generally assumed for such 510(k) submissions that data is generated from studies conducted in a controlled environment, likely a clinical laboratory, but specific details are not provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This type of device (a chemistry analyzer for Calcium levels) typically uses quantitative chemical analysis as its "ground truth" rather than expert interpretation of images or clinical assessments. The reference method for comparison (the predicate device) serves as the standard against which the proposed device is evaluated. Therefore, no human experts are explicitly mentioned for establishing ground truth in the context of diagnostic interpretation.

4. Adjudication Method for the Test Set

Not applicable. The study involved a direct comparison of quantitative measurements from two analytical instruments (proposed device vs. predicate device) on the same samples. There is no mention of human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks where multiple human readers assess cases, and AI assistance is evaluated for its impact on their performance. The described study is a method comparison for a quantitative chemistry analyzer.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the method comparison presented is a standalone performance study of the device (analyzer) itself. The results (n, r, Slope, Intercept, Syx, % Mean Bias) directly reflect the analytical performance of the Dimension® RxL MAX® with AMAS for Calcium measurement when compared to the predicate Dimension® RxL MAX® without AMAS functionality. There is no human-in-the-loop component for this performance evaluation; it's a direct comparison of the instrument's quantitative output.

7. The Type of Ground Truth Used

The "ground truth" for the test set was established by the results obtained from the legally marketed predicate device, the Dimension® RxL Max® (K043546). This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices, where the performance of the new device is compared directly to an already cleared device for the equivalent measurement. The study used a "split-sample method comparison," meaning the same clinical samples were analyzed on both the predicate and proposed devices.

8. The Sample Size for the Training Set

The document does not provide any information regarding a "training set" or its sample size. This is a common omission in 510(k) summaries for in vitro diagnostic (IVD) devices like chemistry analyzers. These devices are typically developed, calibrated, and validated through internal processes by the manufacturer, rather than through a public "training set" as understood in machine learning contexts. The presented method comparison study (n=98) serves as the "test set" for regulatory clearance purposes.

9. How the Ground Truth for the Training Set Was Established

As no training set is explicitly mentioned or described in the provided summary, there is no information on how its ground truth would have been established. It's likely that development and internal validation used various known standards, controls, and patient samples, but these are not disclosed as part of the 510(k) summary focused on the substantial equivalence study.

Summary

{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 ShchurTel: 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 ClinicalChemistry System	K944093	JJE
Dimension® CA Flex ReagentCartridge	K860021	CIC

4. Device Description(s):

{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.

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.

{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® withADVIA® Modular AutomationSystem (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® withADVIA® Modular AutomationSystem (AMAS)
Serum andPlasma SamplePreparation	Manually centrifuged samples.Manually de-capped sample tubes	Manually centrifuged samples orautomatically centrifuged by AMAS.Manually de-capped sample tubes orautomatically de-capped tubes byAMAS
SampleIdentification ofBar-CodedTubes	Tube bar code (identification) is readby the analyzer.	Tube bar code (identification) is readby the Dimension (when tubes areplaceddirectly on the Dimension);orTube bar code read by AMAS andcommunicated electronically to theDimension (when tubes are loadedonto AMAS).
Test Orders	Unidirectional communication with external LIS
Test Results	Unidirectional communication with external LIS
LaboratoryAutomation	Dimension's software communicates with Lab Automation System via LASinterface. Dimension's Sample Transfer Module performs direct samplingfrom 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:

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

Regulation Number and Section

§ 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.