The ALPI method is an in vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma on the Dimension Vista® System. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

ALPI CAL is an in vitro diagnostic product for the calibration of alkaline phosphatase (ALPI) method on the Dimension Vista® System.

Device Description

The ALPI method employs alkaline phosphatase that catalyzes the transphosphorylation of pnitrophenylphosphate (p-NPP) to p-nitrophenol (p-NP) in the presence of the transphosphorylating buffer, 2 amino-2-methyl-1-propanol (AMP). The reaction is enhanced through the use of magnesium and zinc ions. The change in absorbance at 405 nm due to the formation of p-NP is directly proportional to the ALP activity, since other reactants are present in non-rate limiting quantities and is measured using a bichromatic (405, 510 nm) rate technique.

p-NPP + AMP -> p-NP + AMP + PO4 (reaction conditions: pH 10.25, Mg/Zn)

The ALPI CAL is a one (1) level, liquid calibrator. It is packaged as a kit of three vials of Calibrator A (Level 2) with 1.0 mL per vial. The product matrix is a human serum albumin based product containing alkaline phosphatase from porcine kidney. Level 1 is a zero level (system water). Level 2 contains alkaline phosphatase at 1000 U/L.

This product is sold separately from the Flex® reagent cartridge. Values are assigned to new lots from a Masterpool that is from an International Federation of Clinical Chemistry (IFCC) reference.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Dimension Vista® Alkaline Phosphatase Flex® reagent cartridge (ALPI) and Calibrator (ALPI CAL), based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implied by Predicate/Guideline)	Reported Device Performance (Dimension Vista® ALPI)
Method Comparison	Demonstrated substantial equivalence to predicate device (ADVIA® Chemistry Alkaline Phosphatase AMP assay) with acceptable correlation statistics (slope near 1, intercept near 0, high correlation coefficient). While specific numerical acceptance criteria for slope, intercept, and 'r' aren't explicitly stated as "acceptance criteria," the predicate comparison aims to show the new device performs similarly.	Slope: 1.05
Serum/Plasma Comparison	Demonstrated equivalency between serum and lithium heparin plasma with acceptable linear regression statistics (slope near 1, intercept near 0, high correlation coefficient).	Slope: 1.02
Reference Interval	Establishment of a clinically appropriate reference interval for healthy adults.	45-117 U/L [0.75 – 1.95 µkat/L]
Precision	Consistent and reproducible results across various levels, as evaluated by CLSI EP5-A2 with acceptable repeatability and within-lab standard deviation (SD) and coefficient of variation (%CV). No explicit numerical acceptance criteria for %CV or SD are provided, but the presented data demonstrates good precision with low CVs.	Repeatability:- Level 1: 1.0 U/L (2.9% CV)- Level 2: 1.9 U/L (1.2% CV)- Level 3: 4.0 U/L (1.3% CV)- Serum Pool 1: 1.3 U/L (1.7% CV)- Serum Pool 2: 13.6 U/L (1.6% CV)Within-Lab:- Level 1: 1.4 U/L (4.1% CV)- Level 2: 3.1 U/L (2.0% CV)- Level 3: 4.6 U/L (Not legible in original doc)- Serum Pool 1: 1.5 U/L (1.9% CV)- Serum Pool 2: 15.0 U/L (1.8% CV)
Linearity/Measuring Range	Established linear range according to CLSI EP-6A, ensuring accurate measurements within the stated range. The curve fit (R-squared) should show high linearity.	10 - 1000 U/LLinearity Assessment: y = 1.010x + 3.461, R-squared = 0.999
Analytical Specificity/Interferences	Bias due to interferents (hemoglobin, bilirubin, lipemia) should be less than 10%.	Bias < 10% for all tested concentrations of Hemoglobin, Bilirubin (unconjugated and conjugated), and Lipemia (up to 400 mg/dL). (Lipemia at 500 mg/dL tripped a test report message, interference could not be determined).
Limit of Blank (LoB)	LoB value should be close to zero or negative, indicating minimal signal from blank samples.	-0.2 U/L
Limit of Detection (LoD)	LoD value should be low, indicating the lowest concentration reliably detected.	1 U/L
Limit of Quantitation (LoQ)	LoQ value should be low, indicating the lowest concentration at which quantitative results can be reported with a stated accuracy.	8 U/L
Calibrator Stability	Established stability for opened and unopened calibrator for specific durations and storage conditions.	Opened (on system): 7 daysOpened (recapped, 2-8°C): 30 daysShelf Life (unopened): 12 months

Study Information:

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

Method Comparison: 116 patient samples. Data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective), but it is implied to be clinical patient samples.
Serum/Plasma Comparison: 50 matched serum and lithium heparin plasma samples. Data provenance is not explicitly stated.
Reference Interval: 133 healthy adults. Data provenance is not explicitly stated.
Precision:
- 3 levels of Bio-Rad® Multiqual Assayed Quality Controls
- 2 serum pools
Linearity: Not explicitly stated, but likely used serially diluted samples or spiked samples.
Analytical Specificity/Interferences: Not explicitly stated for each interferent, but the study used control samples and test samples for ALPI concentrations of either 278/787, 269/804, 268/799, or 298/849 U/L depending on the interferent.
LoB, LoD, LoQ:
- LoB: 5 samples of Enzyme Diluent (zero level)
- LoD: 5 low-level samples
- LoQ: 3 low-level samples diluted with enzyme diluent

All studies are typical for in vitro diagnostic (IVD) device validation and would generally be considered prospective studies on the new device, comparing it to an established predicate or against defined analytical targets. The summary does not specify the country of origin of the samples.

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

This 510(k) summary describes an in vitro diagnostic assay for measuring alkaline phosphatase. The "ground truth" for such assays typically refers to the true concentration or activity of the analyte in a sample.

No human experts were used to establish "ground truth" for individual test samples in the typical sense of a diagnostic interpretation. Instead, the existing, previously cleared predicate device (ADVIA® Chemistry Alkaline Phosphatase AMP assay) served as the reference for method comparison studies (i.e., its results were considered the "truth" against which the new device was compared).
For the Calibrator ALPI CAL, the summary states that "Calibrator value assignments for anchor pools were assigned by a reference laboratory using the IFCC reference method." The IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) reference method is a highly standardized, internationally recognized method considered a "gold standard" for accuracy. This implies the expertise lies in the adherence to this reference method rather than individual expert readers.

4. Adjudication Method for the Test Set:

Not applicable. This is not a study requiring adjudication of expert interpretations (e.g., medical imaging reviews). The performance is evaluated based on quantitative analytical results measured by the device and compared to reference methods or statistical targets.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. This is an in vitro diagnostic device for quantitative measurement, not an AI-assisted diagnostic imaging or interpretive aid that would involve human readers.

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

Yes. All performance characteristics described (Method Comparison, Precision, Linearity, Interference, LoB/LoD/LoQ) represent the standalone performance of the Dimension Vista® ALPI assay (the algorithm/reagent system) without human interpretive input. The human involvement is limited to operating the instrument, loading samples, and interpreting the numerical output.

7. The Type of Ground Truth Used:

For Method Comparison: The results from the predicate device (ADVIA® Chemistry Alkaline Phosphatase AMP assay) served as the comparative "ground truth" to demonstrate substantial equivalence.
For Calibrator Value Assignment: The IFCC reference method (International Federation of Clinical Chemistry and Laboratory Medicine) was used for assigning values to anchor pools, which then propagated to masterpools and commercial lots. This is a highly standardized, traceable method considered a gold standard for analytical accuracy.
For other analytical studies (Precision, Linearity, LoD/LoQ): The "ground truth" is typically established by carefully prepared samples with known concentrations or by statistical methods inherent to the CLSI guidelines followed.

8. The Sample Size for the Training Set:

This summary does not explicitly mention a "training set" in the context of machine learning. For IVD devices, validation studies (like those listed) are used to characterize performance. The "training" of an IVD assay refers to the development and optimization of the reagent formulation, instrument parameters, and calibration curve, which is an internal process for the manufacturer. The summarized studies are performance validation studies used to demonstrate the device meets its intended use and is safe and effective.

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

Not applicable as there is no mention of a distinct "training set" in a machine learning sense for this IVD assay. The development process for the reagent and assay involves various internal studies and optimizations by the manufacturer to achieve the desired analytical performance. The most relevant form of "ground truth" in the development context would be highly characterized reference materials and reference methods (like the IFCC method for calibration) used to optimize the assay's accuracy and precision.

Summary

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510k Summarv

Dimension Vista® Alkaline Phosphatase Flex® reagent cartridge (ALPI) Dimension Vista® Alkaline Phosphatase Calibrator (ALPI CAL)

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

1. 510(k) Number K122323

2. Applicant: Rose T. Marinelli Siemens Healthcare Diagnostics, Inc. P.O. Box 6101, Newark, DE 19714-6101 Office Number: 302-631-8805; Fax Number: 302-631-6299

Date: July 31, 2012

4. Proprietary and Established Names:

Dimension Vista® Alkaline Phosphatase Flex® reagent cartridge, (ALPI) Dimension Vista® Alkaline Phosphatase Calibrator (ALPI CAL)

5. Regulatory Information:

Alkaline Phosphatase (ALPI) Flex® reagent cartridge

Regulation section: 21 CFR 862.1050 Alkaline phosphatase or isoenzymes test system Classification: Class II Product Code: CJO Panel: Clinical Chemistry

Alkaline Phosphatase Calibrator (ALPI CAL)

Regulation section: 21 CFR 862.1150 Calibrator, Secondary . Classification: Class II Product Code: JIT Panel: Clinical Chemistry

6. Predicate Devices:

The predicate device used to demonstrate substantial equivalence to the Dimension® Alkaline Phosphatase (ALPI) Flex® reagent cartridge is the ADVIA® Chemistry Alkaline Phosphatase AMP Method previously cleared under K991576.

The predicate device used to demonstrate substantial equivalence to the Dimension Vista® Alkaline Phosphatase Calibrator (ALPI CAL) is the Dimension Vista® Alkaline Phosphatase Calibrator previously cleared under K061818.

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7. Device Description:

$$\text{p-NPP} + \text{AMP} \qquad \xrightarrow[\begin{array}{c} \text{pH} \ 10.25\ \text{p-NP} \ \text{10.25} \ \text{Mg/Zn} \end{array}} \qquad \text{p-NP} + \text{AMP} + \text{PO}_4$$

This product is sold separately from the Flex® reagent cartridge. Values are assigned to new lots from a Masterpool that is from an International Federation of Clinical Chemistry (IFCC) reference.

8. Intended Use:

ALPI CAL is an in vitro diagnostic product for the calibration of alkaline phosphatase (ALPI) method on the Dimension Vista® System.

9. Indication(s) for Use:

Same as Intended Use

10. Substantial Equivalence Information:

Both the Dimension Vista® Alkaline Phosphatase Flex® reagent cartridge (ALPI) assay and the predicate ADVIA® Chemistry Alkaline Phosphatase AMP assay employ prepackaged reagents for use on an automated clinical chemistry test systems. A comparison of the similarities and differences between the devices is provided in the following tables:

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Similarities for Dimension Vista® ALPI assay:

Feature	Dimension Vista® Alkaline Phosphatase Flex® reagent cartridgePredicate: ADVIA® Chemistry Alkaline Phosphatase AMP K991576
Intended Use	The ALPI method is an in vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma on the Dimension Vista® System. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.For in vitro diagnostic use in the quantitative determination of alkaline phosphatase in human serum and plasma on the ADVIA® Chemistry systems. Such measurements are used in the diagnosis and treatment of hepatobiliary and bone disease.
Sample Type	Serum and Lithium Heparin Plasma
Measurement	Bichromatic rateRate (RRA)

the state of the state of the state of the states of the states of the states of the states of the states of the states of the states of the states of the states of the state

Differences for Dimension Vista® ALPI assay:

Feature	Dimension Vista® AlkalinePhosphatase Flex® reagent cartridge	Predicate: ADVIA® ChemistryAlkaline Phosphatase AMP MethodK991576
MeasuringRange	10 - 1000 U/L	0 - 1100 U/L
Sample Size	3.48 µL	3 µL

Similarities for Dimension Vista® ALPI Calibrator

Feature	Dimension Vista® AlkalinePhosphatase Calibrator ALPI CAL	Predicate: Dimension Vista®Alkaline Phosphatase CalibratorALP CAL K061818
Intended Use	ALPI CAL is an in vitro diagnosticproduct for the calibration ofalkaline phosphatase (ALPI) methodon the Dimension Vista® System.	The ALP CAL is an in vitrodiagnostic product for thecalibration of Alkaline Phosphatase(ALP) method on the DimensionVista® System.
Preparation	Liquid:Provided ready to use.	Liquid:Provided ready to use.
Storage	2 – 8 °C	2 – 8 °C
TargetConcentrations	Level 2 (CAL A): 1000 U/LNote: Level 1 is System Water	Level 2: (CAL A) 1000 U/LNote: Level 1 is System Water

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Differences for Dimension Vista® ALPI CAL

Feature	Dimension Vista® AlkalinePhosphatase Calibrator ALPI CAL	Predicate: Dimension Vista®Alkaline Phosphatase CalibratorALP CAL K061818
Matrix	Human serum albumin based	Bovine protein based
Traceability	IFCC reference method	Masterpool values

11. Standard/Guidance Document Reference:

· Evaluation of Precision Performance of Quantitative Measurement in Methods; Approved Guideline (EP5-A2)
· Evaluation of the Linearity of Quantitative Measurement Procedures; A Statistical Approach; Approved Guideline (EP6-A)
· Interference Testing in Clinical Chemistry; Approved Guideline (EP7-A2)
· Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline (EP9-A2)
· Protocols for Determination of Limits of Detection and Quantitation; Approved Guideline (EP17-A)
· Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline (C28-A3)

12. Performance Characteristics

The following data represent typical performance for the Dimension Vista® System and were collected on a Dimension Vista® 500.

Method Comparison

Split sample comparison between the Dimension Vista® Alkaline Phosphatase assay and the ADVIA® Chemistry Alkaline Phosphatase AMP assay gave the following correlation statistics, when tested with patient samples:

DimensionVista®	Predicate	Slope	Intercept U/L	CorrelationCoefficient (r)	n
ALPI	ADVIA®ALPAMP	1.05	-0.4	0.999	116

Dimension® Alkaline Phosphatase (ALPI) vs. Predicate

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Serum/Plasma Comparison

To demonstrate equivalency between serum and lithium heparin plasma for Dimension Vista® ALPI, comparison testing of 50 matched serum and lithium heparin plasma samples were tested on the Dimension Vista® System and gave the following linear regression statistics:

Serum vs.	Slope	Intercept U/L	CorrelationCoefficient (r)	n
LithiumHeparinPlasma	1.02	-7.7	0.999	50

Serum vs. Plasma Comparison Data

Reference Interval (Expected Values)

Samples were collected from 133 healthy adults and analyzed with the Dimension® ALPI method. The reference interval was calculated non-parametrically and represents the central 95% of results determined from the population.

Expected Values: 45-117 U/L [0.75 – 1.95 µkat/L]

Precision

Precision testing was performed in accordance with CLSI EP5-A2 Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second Edition. Samples consisted of three levels of Bio-Rad® Multiqual Assayed Quality Controls and two serum pools. Testing was performed over 20 days, two separate runs with two test samples for each test material. Analysis of variance (ANOVA) was used to evaluate the data consistent with the recommendations of EP5-A2. The data are summarized in the following Dimension Vista® Alkaline Phosphatase (ALPI) Summary Table:

	Mean (U/L)	Repeatability		Within-Lab
Sample n=80		SD (U/L)	%CV	SD(U/L)	%CV
BioRad® Multiqual Assayed QC
Level l	34	1.0	2.9	1.4	4.1
Level 2	। રેર	1.9	1.2	3.1	2.0
Level 3	301	4.0	1.3	4.6	ાં 'રે
Pools
Serum Pool 1	78	1.3	1.7	1.5	1.9
Serum Pool 2	833	। 3.6	1.6	15.0	1.8

Linearity

The linear range was determined according to CLSI EP-6A, Evaluation of the Linearity of Quantitative Measurement Procedures; A Statistical Approved Guideline. Based on the results of this

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testing and the Limit of Detection testing on the Dimension Vista® System, the analytical measurement range was determined to be 10 – 1000 U/L.

Image /page/5/Figure/1 description: The image shows a graph titled "Vista ALPI Linearity Assessment with High Serum Pool". The x-axis is labeled "Expected ALPI Concentration (U/L)" and ranges from 0 to 1200. The y-axis is labeled "Observed ALPI Concentration (U/L)" and ranges from 0 to 1200. A line of best fit is plotted on the graph, and the equation of the line is y = 1.010x + 3.461, with an R-squared value of 0.999.

Analytical Specificity/Interferences

The ALPI method was evaluated for interference according to CLSI EP7-A2 Interference Testing in The Ferrance The over as over wed Guideline - Second Edition. 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.

Substance Tested	Substance Concentration	Alkaline PhosphataseU/L [µkat/L]	Bias%
Hemoglobin(hemolysate)	1000 mg/dL [0.62 mmol/L]	278 [4.641]787 [13.14]	<10<10
Bilirubin(unconjugated)	60 mg/dL [1026 µmol/L]	269 [4.49]804 [13.43]	<10<10
Bilirubin(conjugated)	60 mg/dL [1026 µmol/L]	268[4.48]799 [13.34]	<10<10
Lipemia(Intralipid®)	400 mg/dL [4 g/L]	298 [4.98]849 [14.18]	<10<10
	500 mg/dL [5 g/L]	299 [4.99]850 [14.20]	jj

j. Lipemia (Intralipid") at 500 mg/dL [5 g/L] and above tripped a test report message; interference could not be determined.

Studies were also performed following CLSI EP7-A2 for Interference Testing of exogenous substances at an alkaline phosphatase concentration of 286 U/L and 799 U/L and were found not to interfere with the

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ALPI method when present in serum and plasma. Inaccuracies (biases) were all less than 10%. See Dimension Vista® ALPI Instructions for Use for a full list of substances tested.

Limit of Blank, Limit of Determination and Limit of Quantitation

The Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ) was evaluated in accordance with CLSI EP17-A Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline. Studies were performed on the Dimension® clinical chemistry analyzer with the following results:

Dimension® Alkaline Phosphatase (ALPI)
Limit	Protocol	Value
LoB	5 samples of Enzyme Diluent(zero level) were tested for 3days, one run per day, 2replicates per run, 2 reagent lots,1 instrument	-0.2 U/L
LoD	5 low level samples were testedfor 3 days, one run per day, 2replicates per run, 2 reagent lots,1 instrument	1U/L
LoQ	3 low level samples diluted withenzyme diluent were tested for 3days, one run per day, 3replicates per run, 2 reagent lots,1 instrument	8 U/L

Calibrator Stability and Value Assignment:

For opened products, once the cap is removed, assigned values are stable for 7 days stored on the . Dimension Vista® System.
Once cap is removed, assigned values are stable for 30 days when recapped immediately after use . and stored at 2-8℃. Do not use this vial on board the instrument.

The shelf life of the Dimension Vista® Alkaline Phosphatase Calibrator (ALPI CAL) is 12 months. For unopened product, see the expiration date on the calibrator carton.

Calibrator value assignments for anchor pools were assigned by a reference laboratory using the IFCC reference method. Masterpools are assigned in-house from anchor pools and commercial lots are assigned from the Masterpools using Dimension Vista® System.

Conclusion: The Dimension Vista® Alkaline Phosphatase (ALPI) Flex® reagent cartridge with the associated Dimension Vista® Alkaline Phosphatase Calibrator (ALPI CAL) are substantially equivalent in principle and performance to the ADVIA® Chemistry Alkaline Phosphatase AMP assay and Dimension Vista® Alkaline Phosphatase (ALP) calibrator respectively.

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Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Siemens Healthcare Diagnostics, Inc c/o Rose T. Marinelli 500 GBC Drive, MS 514 Newark, DE 19702

AUG 2 8 2012

K122323 Re:

Trade Name: Dimension Vista® Alkaline Phosphatase Flex®reagent cartridge, (ALPI) Dimension Vista® Alkaline Phosphatase Calibrator (ALPI CAL) Regulation Number: 21 CFR §862.1050 Regulation Name: Alkaline phosphatase or isoenzymes Test System Regulatory Class: Class II Product Codes: CJO, JIT Dated: July 31, 2012 Received: August 1, 2012

Dear Ms Marinelli::

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 approvisions 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 (1 wr 1), it is a 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 modified in any Federal statutes and regulations administered by other Federal agencies. of mo recordly 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 and nismig (21 % 10 % 10 % = 10 % = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice 10. your as . Device Evaluation and Safety at (301) 796-5450. Also, comact the other of in Vitro Diaghosing by reference to premarket notification" (21 please note the regulation chance, "Minner," while and surveillance, please contact CDRH301 CI'K Fall 607.77). For questions regarding postmarket Surveillance at (301)
Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) Office of Surveinance and Diolineare a (Oorting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

CI K Fall 803), picaso go to impliw will 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 Tou may other only Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

Couriney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): _ K 122323

Device Name: Dimension Vista® Alkaline Phosphatase Flex® reagent cartridge (ALPI)

Indications for Use:

The ALPI method is an in vitro diagnostic test for the quantitative measurement of alkalinc phosphatase in human serum and plasma on the Dimension Vista® System. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device

Evaluation and Safety

510(k) K122323

Page 1 of

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Indications for Use Form

510(k) Number (if known): __ K 122323

Device Name: Dimension Vista® Alkaline Phosphatase Calibrator (ALPI CAL)

Indications for Use:

ALPI CAL is an in vitro diagnostic product for the calibration of alkaline phosphatase (ALPI) method on the Dimension Vista@ System.

Prescription Use ਮ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics Devices (OIVD)

Yung Chan

Division Sign-Off

Office of In Vitro Diagnostic Device

Evaluation and Safety

sio(k) K122323

Page Jo of _2

Regulation Number and Section

§ 862.1050 Alkaline phosphatase or isoenzymes test system.

(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.