For in vitro diagnostic use in the quantitative measurement of albumin in human serum or plasma on ADVIA Chemistry systems. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.

For in vitro diagnostic use in the calibration of the ADVIA Chemistry Albumin BCP Assay (ALBP) on ADVIA Chemistry systems.

Device Description

The Albumin BCP reagents are ready-to-use liquid reagents packaged for use on the automated ADVIA 1650 Chemistry systems. Reagents are supplied in two configurations: fill volume of 18 mL in a 20 mL wedge or 35 mL in a 40 mL wedge, 4 wedges/kit.

The calibrator is a multi-analyte human serum based product containing albumin derived from human serum. The kit consists of 3 vials of one-level calibrator which are lyophilized. The target concentration of this calibrator is 4.3 g/dL. The volume per vial (after reconstitution with deionized water) is 2.0 mL.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a separate section with specific numerical thresholds for each performance characteristic. Instead, it describes various performance studies and concludes that the results were "acceptable" and support "substantial equivalence" to the predicate device. For the purpose of this analysis, I will infer general acceptance by demonstrating performance comparable to or better than the predicate, or by meeting internal and CLSI guidelines for analytical performance.

Performance Characteristic	Acceptance Criteria (Inferred/Implicit)	Reported Device Performance (ADVIA Chemistry Albumin BCP Assay ALBP)
Precision	CVs within acceptable clinical limits (e.g., <10% for LoQ) and comparable to predicate device.	Serum Control (2.7 g/dL): Total CV 1.5%Serum Control (4.0 g/dL): Total CV 1.0%Serum Pool (3.5 g/dL): Total CV 0.0%Serum Pool (5.2 g/dL): Total CV 0.9% (All within CLSI EP5-A2 guidelines)
Linearity/Assay Reportable Range	Observed values should correlate strongly with expected values (e.g., R close to 1) and cover the intended measuring range.	Linear range: 0.6 - 8.0 g/dL. Linear regression: Y = 1.016x - 0.05, R = 1.000.
Limit of Blank (LoB)	LoB < LoD, demonstrating ability to distinguish blank from low-level analyte.	0.1 g/dL
Limit of Detection (LoD)	Smallest amount reliably detected with low false positive/negative rates (e.g., <5%).	0.6 g/dL (false positive/negative rates <5%)
Limit of Quantitation (LoQ)	LoQ demonstrating acceptable precision (e.g., <10% CV).	0.6 g/dL (<10% CV inter-assay precision)
Method Comparison with Predicate Device	Strong correlation with predicate (e.g., R close to 1, slope close to 1, intercept close to 0).	Linear regression: 0.99 (predicate) + 0.01 g/dLSlope 95%CI: 0.98 - 1.00Intercept 95% CI: -0.03 - 0.05r = 0.999Sample range: 0.9 - 7.9 g/dL
Matrix Comparison (Plasma vs. Serum)	Strong correlation between plasma and serum results (e.g., R close to 1, slope close to 1, intercept close to 0).	Lithium Heparin Plasma vs. Serum:Regression: 1.01 (Serum) + 0.04 g/dLSlope 95%CI: 0.99 - 1.03Intercept 95% CI: -0.05 - 0.12r = 0.998Sample range: 1.0 - 7.8 g/dLPotassium EDTA Plasma vs. Serum:Regression: 0.99 (Serum) - 0.06 g/dLSlope 95%CI: 0.96 - 1.03Intercept 95% CI: -0.23 - 0.07r = 0.993Sample range: 1.0 - 7.7 g/dL
Analytical Specificity (Interference)	Bias < 10% from common interferents at clinically relevant high concentrations.	Bilirubin (up to 60 mg/dL), lipemia (up to 525 mg/dL), and hemoglobin (up to 750 g/dL) did not cause significant interference (i.e., bias < 10%).
Reagent and Calibrator Stability	Demonstrate acceptable stability over typical usage and shelf life periods.	Reagent: On-system 60 days, shelf life 12 months at 2-8°C.Calibrator: Opened 8 hours (re-capped at 2-8°C), shelf life 18 months at 2-8°C.
Traceability	Traceable to an established reference material.	Traceable to ERM-DA470k Reference Material.
Calibrator Value Assignment Target Range	Established, consistent target value for the calibrator.	Target: 4.3 g/dL (Range: 4.1 to 4.5 g/dL)

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

Precision:
- Serum sample pools and serum-based controls were assayed.
- Each sample was assayed 2 replicates per run, 2 runs per day, for at least 20 days.
- Number of data points (N) for each control/pool: 80.
- Provenance: Not explicitly stated, but clinical laboratory studies typically use samples from diverse patient populations to represent the intended use environment. The term "Serum Control" and "Serum Pool" suggest internally generated or purchased control materials, which are representative of human serum. Retrospective, as these are controlled studies based on pre-collected samples or control materials.
Linearity/Assay Reportable Range:
- Eleven dilutions across the measuring range.
- Provenance: Not explicitly stated, but likely laboratory-prepared dilutions of human serum or control materials. Retrospective.
Limit of Blank, Limit of Detection, Limit of Quantitation:
- 720 determinations: 240 blank replicates and 480 low-level sample replicates.
- Provenance: Not explicitly stated, but laboratory-prepared blank and low-level samples. Retrospective.
Method Comparison with Predicate Device:
- Sixty-nine (69) serum samples.
- Provenance: Not explicitly stated, but these would be human serum samples covering a range of albumin concentrations. Retrospective, as samples are collected and then tested.
Matrix Comparison:
- Forty-seven (47) paired plasma/serum samples (Lithium Heparin and Potassium EDTA plasma vs. serum).
- Provenance: Human plasma and serum samples. Retrospective.
Analytical Specificity (Interference):
- Not specified, but likely involved multiple spiked samples for each interferent at varying concentrations.
- Provenance: Laboratory-prepared samples spiked with interferents. Retrospective.

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

This document describes a diagnostic assay for quantitative measurement of albumin. The "ground truth" in this context is the actual albumin concentration in the samples, determined by a reference method or validated control materials, not by expert interpretation of images or clinical cases.

No human experts are used for establishing "ground truth" in the interpretive sense (e.g., radiologist for imaging).
The "ground truth" is established analytically:
- Through the inherent reference values of commercial controls.
- By the established methodology of the predicate device.
- By traceability to the ERM-DA470k Reference Material.
- By preparing samples with known (expected) concentrations for linearity and LoQ studies.
- The "experts" involved are implied to be laboratory scientists and method developers who establish and validate these analytical reference points based on established scientific principles and guidelines (e.g., CLSI).

4. Adjudication Method for the Test Set:

Not applicable. This is an analytical chemistry assay, not a device requiring human interpretation and multi-reader adjudication for ground truth establishment. The performance is assessed against quantitative analytical targets.

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 other interpretive devices where human readers provide diagnoses, and the AI assists or performs the interpretation. This device is a quantitative chemistry assay.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, all studies described (precision, linearity, LoB/LoD/LoQ, method comparison, matrix comparison, analytical specificity) are standalone performance evaluations of the ADVIA Chemistry Albumin BCP Assay on the ADVIA 1650 Chemistry system. The device (assay and instrument combination) performs the measurement automatically without human intervention once the sample is loaded.

7. The Type of Ground Truth Used:

The ground truth for the performance studies is primarily derived from:

Known concentrations: For linearity, LoB, LoD, and LoQ studies, samples are prepared with known (expected) albumin concentrations or are blank.
Reference materials: Traceability to ERM-DA470k Reference Material provides a foundation for accurate quantification.
Predicate device measurements: For method comparison, the results from the legally marketed predicate device (Dimension Clinical Chemistry System Albumin Flex® reagent cartridge) serve as a comparative ground truth.
Validated control materials: Commercial serum controls with established target values.

8. The Sample Size for the Training Set:

The document describes an analytical assay, not an AI/ML algorithm that undergoes a distinct "training" phase. Therefore, there is no explicit "training set" in the context of machine learning. The assay's performance characteristics (e.g., reagent formulations, instrument parameters, calibration curves) are developed and validated through extensive internal R&D and optimization processes, which would involve numerous samples, but these are not referred to as a "training set" in the same way an ML model would have one.

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

As noted above, there isn't a "training set" in the AI/ML sense. The "ground truth" for the development and optimization of the assay and its associated calibrator involves:

Reference methods for quantifying albumin.
Gravimetric or optical methods for preparing known concentration standards.
Traceability to international reference materials like ERM-DA470k.
Empirical data collected during the assay development process to optimize reagent concentrations, reaction conditions, and instrument parameters to achieve desired analytical performance.

Summary

{0}------------------------------------------------

510(k) Summary of Safety and Effectiveness for the ADVIA® 1650 Chemistry Albumin BCP Assay (ALBP)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

1. 510(k) Number: _k132664
1. Applicant:

Address: Phone:

Contact: Kira Gordon, PhD Sr. Regulatory Affairs Specialist Siemens Healthcare Diagnostics, Inc 511 Benedict Ave, Tarrytown, NY 10591 (914) 524-2996 (914) 524-2500 (FAX)

OCT 1 6 2013

1. Date: August 26, 2013

4. Proprietary and Established Names:

ADVIA Chemistry Albumin BCP Assay (ALBP) ADVIA Chemistry Albumin BCP Calibrator

5. Regulatory Information:

Reagent
Regulation section: 21 CFR §862.1035, bromcresol purple dye-binding, albumin Classification: Class II Product Code: CJW · Panel: Clinical Chemistry (75)

Calibrator

Regulation section: 21 CFR §862.1150, calibrator, multi-analyte mixture Classification: Class II Product Code: JIX Panel: Clinical Chemistry (75)

6. Predicate Device:

Reagent

Device Name: Dimension Clinical Chemistry System Albumin Flex reagent cartridge Common Name: Dimension Clinical Chemistry System Albumin Assay 510(k) Number: K861700 Manufacturer: Siemens Healthcare Diagnostics, Inc.

Page 1 of 7

{1}------------------------------------------------

Calibrator

Device Name: Dimension Clinical Chemistry System TP/ALB Calibrator Common Name: Dimension Clinical Chemistry System TP/ALB Calibrator 510(k) Number: K861700 Manufacturer: Siemens Healthcare Diagnostics, Inc.

7. Intended Use:

See Indications for Use

8. Indications for Use:

For in vitro diagnostic use in the calibration of the ADVIA Chemistry Albumin BCP Assay (ALBP) on ADVIA Chemistry systems.

9. Device Description:

10. Test Principle:

The ADVIA Chemistry Albumin BCP Assay is an adaptation of the bromocresol purple (BCP) dye-binding method reported by Carter and Louderback, et al. In the ADVIA Chemistry ALBP Assay, serum or plasma albumin quantitatively binds to BCP to form an albumin-BCP complex that is measured as an endpoint reaction at 596/694 nm.

11. Substantial Equivalence Information:

Predicate device name: Dimension Clinical Chemistry System Albumin Flex® reagent cartridge (ALB) Dimension Clinical Chemistry System TP/ALB Calibrator 2

Predicate K number: K861700

Page 2 of 7

{2}------------------------------------------------

Reagent:Item	New Device:ADVIA Chemistry Albumin BCPAssay (ALPB)	Predicate Device: SiemensDimension ClinicalChemistry SystemAlbumin Flex® reagentcartridge (ALB)
Analyte	Albumin	Same
Intended Use/Indications for Use	For in vitro diagnostic use in thequantitative measurement of albumin inhuman serum or plasma on ADVIAChemistry systems.Albumin measurements are used in thediagnosis and treatment of numerousdiseases primarily involving the liver orkidneys.	For in vitro diagnostic use inthe quantitative measurementof albumin in human serum orplasma.
Instrument to beused	ADVIA 1650 Chemistry System	Dimension ClinicalChemistry System
Measurement	quantitative	Same
Sample type	Serum, Plasma	Same
Reference interval	3.4 - 5.0 g/dL	Same
Format	Liquid	Same
Use of Calibrators	Yes	Same
Analyticalmeasuring interval	0.6 - 8.0 g/dL	Same
Method Principle	bromocresol purple (BCP) dye-bindingmethod	Same
Reagents	Single reagent	Same
Standardization	ERM-DA470k Reference Material	Same

Calibrator

Item	New Device:ADVIA Chemistry Albumin BCPCalibrator	Predicate Device: SiemensDimension ClinicalChemistry SystemTP/ALB calibrator
Intended Use	For in vitro diagnostic use in thecalibration of the ADVIA ChemistryAlbumin BCP Assay (ALBP) on ADVIAChemistry systems	for in vitro diagnostic use inthecalibration of Albumin BCPAssay
Instrument	ADVIA 1650 Chemistry System	Dimension ClinicalChemistry System
Measured Analytes(value assigned)	Albumin	Albumin, Total Protein

{3}------------------------------------------------

Form	Lyophilized	Same
Matrix	Human serum	Same
Analyte source	Human source	Same
Number of levels	One	Three
Fill Volume	Reconstitute with 2 mL DI water	Same

12. Standard/Guidance Document Reference

Interference Testing in Clinical Chemistry: Approved Guideline Second Edition (CLSI . EP7-A2)
Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; . Approved Guideline - Second Edition (CLSI EP17-A2)
Evaluation of Precision Performance of Quantitative Measurement Methods: Approved . Guideline-Second Edition (CLSI EP5-A2)

13. Performance Characteristics

The following data represent typical performance for the ADVIA Chemistry Albumin BCP Assay and were collected on ADVIA 1650 Chemistry system. Substantial equivalence was demonstrated by testing several performance characteristics including precision, method comparison, interfering substances and analytical range. All of the evaluation studies gave acceptable results when compared to the predicate device. These studies support that the ADVIA Chemistry Albumin BCP Assay is substantially equivalent to the predicate device.

1. Precision

Within run and Total Precision were established by Assaying serum sample pools and serum based controls. Each sample was Assaved 2 replicates per run, 2 runs per day, for at least 20 days. Precision estimates were computed according to CLSI document EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline.

		MEAN	Within Run		Between Run		Between Day		Total
Product	N	g/dL	SD	CV	SD	CV	SD	CV	SD	CV
Serum Control	80	2.7	0.03	0.9	0.00	0.0	0.03	1.2	0.04	1.5
Serum Control	80	4.0	0.03	0.7	0.01	0.3	0.03	0.6	0.04	1.0
Serum Pool	80	3.5	0.00	0.0	0.00	0.0	0.00	0.0	0.00	0.0
Serum Pool	80	5.2	0.04	0.7	0.02	0.3	0.02	0.4	0.05	0.9

2. Linearity/Assay reportable range

Linearity of the Assay on ADVIA 1650 Chemistry system was assessed by evaluating eleven dilutions across the measuring range.. All samples were tested on the ADVIA 1650 Chemistry analyzer. Observed values were compared vs. expected values using linear regression analysis. The low end of the assay range is calculated based on the Limit of Quantitation. The high end of the assay range is based on the linearity calculations.

{4}------------------------------------------------

The linear/measuring range of the assay is 0.6 to 8.0 g/dL.

Image /page/4/Figure/1 description: The image is a linear regression plot titled "ADVIA 1650 Albumin BCP - Linearity, Linear Regression (Observed vs. Expected)". The x-axis is labeled "Expected g/dL" and ranges from 0.0 to 10.0, while the y-axis is labeled "Observed g/dL" and also ranges from 0.0 to 10.0. A linear regression line is plotted on the graph, and the equation of the line is given as Y = 1.016 x - 0.05, with R = 1.000 and N = 11.

3. Limit of Blank, Limit of Detection, Limit of Quantitation

The estimations of the Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ) were performed according to CLSI document EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures, Approved Guideline. The LoB for the ADVIA Chemistry Albumin BCP Assay on the ADVIA 1650 Chemistry system is 0.1 g/dL. Limit of detection (LoD) is the smallest amount that this Assay can reliably detect to determine presence of an analyte. The LoD for for the ADVIA Chemistry Albumin BCP Assay on the ADVIA 1650 Chemistry system is 0.6 g/dL. LoB and LoD values are determined with proportions of false positives (a) less than 5% and false negatives (B) less than 5%, based on 720 determinations with 240 blank and 480 low-level sample replicates. . Limit of Quantitation (LoQ) is 0.6 g/dL based on an inter-assay precision of <10% CV.

4. Method comparison with predicate device

The performance of the ADVIA Chemistry Albumin BCP Assay (y) for serum samples on ADVIA 1650 Chemistry system was compared with the performance of the predicate device (x). Sixty-nine serum samples with albumin concentrations throughout the range of the assay were tested. The results calculated using least squares linear regression (1d replicate) are as follows:

ADVIA Chemistry Albumin BCP = 0.99 (predicate device) + 0.01 g/dL Slope 95%CI: 0.98 - 1.00

Page 5 of 7

{5}------------------------------------------------

Intercept 95% CI: -0.03 - 0.05 Sample range: 0.9 - 7.9 g/dL r=0.999

5. Matrix comparison

The performance of the ADVIA Chemistry Albumin BCP Assay (y) was compared on ADVIA 1650 Chemistry system for plasma samples (Lithium Heparin and Potassium EDTA) vs. serum samples (x). Forty seven paired plasma/serum samples with albumin concentrations throughout the range of the assay were tested. The results calculated using linear regression (15 replicate) are as follows:

ADVIA Chemistry Albumin BCP Plasma (Lithium Heparin) = 1.01 (ADVIA Chemistry Albumin BCP Serum) + 0.04 g/dL Slope 95%CI: 0.99 - 1.03 Intercept 95% CI: -0.05 - 0.12 Sample range: 1.0 - 7.8 g/dL r=0.998

ADVIA Chemistry Albumin BCP Plasma (Potassium EDTA) = 0.99 (ADVIA Chemistry Albumin BCP Serum) - 0.06 g/dL Slope 95%CI: 0.96 - 1.03 Intercept 95% CI: -0.23 - 0.07 Sample range: 1.0 - 7.7 g/dL r=0.993

6. Analytical specificity

Interferences from icterus, lipemia, and hemolysis, factor were evaluated using a significance criterion of >10% bias. Bias is the difference in the results between the control sample (without the interferent) and the test sample (contains the interferent) expressed in percent. Bias exceeding 10% is considered interference.

Bilirubin (conjugated and unconjugated) tested up to 60 mg/dL, lipemia up to 525 mg/dL and hemoglobin up to 750 g/dL were shown not to cause significant interference with this assay.

Reference Interval (Expected Values)

Expected values are within 3.4 - 5.0 g/L **

** Willey DA, Savory J, Lasky F. An Evaluation of a Revised Albumin Method for the aca@ discrete clinical analyzer, Du Pont Company, Wilmington, DE, August 1982

Siemens provides this information for reference. As with all in vitro diagnostic Assays each laboratory should determine its own reference ranges for the diagnostic evaluation of patient results.

8. Reagent and Calibrator Stability:

Reagent: for opened products, once placed on the system reagents are stable for 60 days. The shelf life of the ADVIA Chemistry Albumin BCP Reagent is 12 months at 2-8°C. For unopened product, see the expiration date on the reagent carton.

{6}------------------------------------------------

Calibrator: for opened products, once the cap is removed, assigned values are stable for 8 hours when recapped immediately after use and stored at 2-8℃. The shelf life of the ADVIA Chemistry Albumin BCP Calibrator is 18 months at 2-8°C. For unopened product, see the expiration date on the calibrator carton.

The calibrator which is used for the ADVIA Chemistry Albumin BCP assay is the same calibrator (one level only) which was previously cleared as Siemens Dimension Clinical Chemistry System TP/ALB calibrator under K861700 and is relabeled for ADVIA Chemistry use

9. Traceability

The ADVIA Chemistry Albumin BCP Assay is traceable to ERM-DA470k Reference Material. Assigned values of the ADVIA Chemistry Albumin BCP Calibrator are traceable to this standardization

10. Value Assignment

The value assignment protocol for the ADVIA Chemistry Albumin BCP calibrator is the same as for the predicate device which was cleared under K861700.

Target, g/dL	4.3
Target Range, g/dL	4.1 to 4.5

14. Conclusions

The ADVIA Chemistry Albumin BCP Assay with associated calibrator on ADVIA 1650 Chemistry system is substantially equivalent in principle and performance to the Siemens Healthcare Diagnostics Dimension Albumin Assay reagent and Dimension TP/ALB calibrator respectively, cleared under K861700.

{7}------------------------------------------------

Image /page/7/Picture/0 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 emblem featuring three angled shapes resembling a bird in flight or a series of waves.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 16, 2013

Siemens Healthcare Diagnostics, Inc. C/O Kira Gordon, Ph.D. 511 Benedict Ave. TARRYTOWN NY 10591

Re: K132664

Trade/Device Name: ADVIA Chemistry Albumin BCP Assay (ALBP) ADVIA Chemistry Albumin BCP Calibrator Regulation Number: 21 CFR 862.1035 Regulation Name: Albumin test system Regulatory Class: II Product Code: CJW, JIX Dated: August 26, 2013 Received: August 27, 2013

Dear Dr. Gordon:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{8}------------------------------------------------

Page 2-Dr. Gordon

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincercly yours,

Carol C. Benson -S for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{9}------------------------------------------------

Indications for Use

510(k) Number (if known): K132664

Device Name:

ADVIA Chemistry Albumin BCP Assay (ALBP) ADVIA Chemistry Albumin BCP Calibrator

Indications for Use:

For in vitro diagnostic use in the calibration of the ADVIA Chemistry Albumin BCP Assay (ALBP) on ADVIA Chemistry Systems.

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 Diagnostics and Radiological Health (OIR)

Image /page/9/Picture/12 description: The image shows the name "Yung W. Chan -S" in a bold, sans-serif font. The letters are large and clearly legible. The name appears to be a signature or heading, possibly indicating the author or subject of a document.

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K132664

Regulation Number and Section

§ 862.1035 Albumin test system.

(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.