The ALPI method is an in vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma on the Dimension® clinical chemistry 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® clinical chemistry system.

Device Description

The ALPI method employs alkaline phosphatase that catalyzes the transphosphorylation of pnitropheny | phosphate (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.

The ALPI CAL is a three (3) level, liquid calibrator. It is packaged as a kit of six vials, two vials per level (1, 2 and 3) with 1.0 mL per vial. The product matrix is a human serum albumin based product containing alkaline phosphatase from porcine kidney. Levels 2 and 3 contain alkaline phosphatase at the following concentrations.

Level 1: 0 U/L
Level 2: 500 U/L
Level 3: 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 the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Criteria (Test)	Acceptance Criteria (Implied)	Reported Device Performance
Method Comparison	Strong correlation (r ≈ 1) and minimal bias compared to predicate device.	ALPI vs. ADVIA® ALPAMP: Slope: 1.06; Intercept: -0.4 U/L; Correlation Coefficient (r): 0.999.
Serum/Plasma Comparison	Strong correlation (r ≈ 1) and minimal bias between serum and plasma samples.	Serum vs. Lithium Heparin Plasma: Slope: 1.02; Intercept: -5.08 U/L; Correlation Coefficient (r): 0.999.
Reference Interval	Established expected range for healthy adults.	Expected Values: 46-116 U/L [0.77 - 1.94 µkat/L] (representing the central 95% of results).
Precision (Repeatability & Within-Lab)	Low coefficient of variation (CV%) for various control levels and serum pools.	Repeatability:- BioRad QC Level 1: Mean 37 U/L, SD 0.6 U/L, %CV 1.5- BioRad QC Level 2: Mean 157 U/L, SD 1.0 U/L, %CV 0.6- BioRad QC Level 3: Mean 303 U/L, SD 3.3 U/L, %CV 1.1- Serum Pool 1: Mean 81 U/L, SD 1.1 U/L, %CV 1.4- Serum Pool 2: Mean 842 U/L, SD 5.7 U/L, %CV 0.7Within-Lab:- BioRad QC Level 1: SD 1.6 U/L, %CV 4.2- BioRad QC Level 2: SD 3.7 U/L, %CV 2.3- BioRad QC Level 3: SD 7.1 U/L, %CV 2.4- Serum Pool 1: SD 1.8 U/L, %CV 2.2- Serum Pool 2: SD 13.3 U/L, %CV 1.6
Linearity	Analytical measurement range demonstrates linear response.	Analytical measurement range: 10 - 1000 U/L. Scatter plot showed y = 0.9868x + 9.7726 with R-squared = 0.9992.
Analytical Specificity/Interferences	Bias due to common interferents (hemoglobin, bilirubin, lipemia) < 10%.	- Hemoglobin (1000 mg/dL): <10% bias at 297 U/L and 823 U/L.- Bilirubin (unconjugated 80 mg/dL): <10% bias at 300 U/L and 834 U/L.- Bilirubin (conjugated 80 mg/dL): <10% bias at 307 U/L and 856 U/L.- Lipemia (Intralipid® 500 mg/dL): <10% bias at 308 U/L and 878 U/L.- Lipemia (Intralipid® 600 mg/dL): Tripped an error flag; interference could not be determined. Exogenous substances showed <10% bias at 299 U/L and 842 U/L.
Limit of Blank (LoB)	Established lowest analyte concentration with no false positives.	LoB: 3 U/L.
Limit of Detection (LoD)	Established lowest analyte concentration reliably detected.	LoD: 8 U/L.
Limit of Quantitation (LoQ)	Established lowest analyte concentration accurately quantified.	LoQ: 9 U/L.

Study Details

This document describes performance characteristics typically reported for an in vitro diagnostic device, primarily focused on analytical performance and comparison to a predicate device. It does not appear to involve a study of an AI/ML algorithm or human-in-the-loop performance.

Sample sizes used for the test set and the data provenance:
- Method Comparison: 116 patient samples. Data provenance not explicitly stated (e.g., country of origin, retrospective/prospective), but implied to be human patient samples.
- Serum/Plasma Comparison: 50 matched serum and lithium heparin plasma samples. Data provenance not explicitly stated.
- Reference Interval: 132 healthy adults. Data provenance not explicitly stated.
- Precision: Not based on patient samples directly; used three levels of Bio-Rad® Multiqual Assayed Quality Controls and two serum pools.
- Linearity: n=9 samples (based on the figure description). Data provenance not explicitly stated.
- Analytical Specificity/Interferences: Multiple samples tested with specific interferent concentrations (e.g., 2 samples for hemoglobin interference testing, 2 samples for bilirubin).
- Limit of Blank, Limit of Detection, Limit of Quantitation: 5 samples for LoB, 5 low-level samples for LoD, 3 low-level samples diluted for LoQ.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to the device described. The studies measure the device's analytical performance against established laboratory standards and reference methods (e.g., predicate device, CLSI guidelines), not against expert determination of a medical condition. For example, "ground truth" for Alkaline Phosphatase levels comes from the actual concentration measured by a reference method or predetermined controls, not from expert consensus.
Adjudication method for the test set:
- This is not applicable as the studies focus on analytical performance and quantitative measurements, not on qualitative interpretations requiring adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a chemistry analyzer reagent and calibrator kit, not an AI/ML-driven diagnostic tool that would typically involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The studies described are for the standalone analytical performance of the in vitro diagnostic device (reagent and calibrator) on a clinical chemistry system. This device is not an algorithm in the sense of AI/ML, but rather a chemical assay. Its performance is evaluated independently of human interpretation of the result it produces, though a human still interprets the clinical significance of that result.
The type of ground truth used:
- Method Comparison: The predicate device (ADVIA® Chemistry Alkaline Phosphatase AMP assay) served as the comparative "truth" for evaluating the new device's accuracy.
- Serum/Plasma Comparison: Matched serum and lithium heparin plasma samples were used, where the goal was to show equivalence between the two sample types, implying their respective results represent the "truth" for that sample.
- Reference Interval: Results from 132 healthy adults defined the expected range, serving as an epidemiological ground truth for a heathy population.
- Precision: Bio-Rad® Multiqual Assayed Quality Controls and serum pools with known target values served as the ground truth.
- Linearity: Expected ALP values derived from dilution series served as the ground truth.
- Analytical Specificity/Interferences: Control samples (without interferent) and test samples (with known interferent concentrations) were used, with the control samples representing the baseline truth.
- Limit of Blank, Limit of Detection, Limit of Quantitation: Enzyme Diluent (zero level) and specifically prepared low-level samples were used, with the known concentrations serving as the ground truth.
- Overall, the ground truth relies on established reference methods, validated controls, known concentrations, and epidemiological data from healthy populations.
The sample size for the training set:
- This concept of a "training set" is not applicable. This is a traditional in vitro diagnostic device, not an AI/ML system that requires a training set for model development. The development of the reagents and assay method would involve R&D and optimization, but not in the same sense as training an algorithm on a dataset.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the AI/ML context for this device.

Summary

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

JUL 2 3 2012

510k Summary

Dimension® Alkaline Phosphatase Flex® reagent cartridge (ALPI) Dimension® 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.

A. 510(k) Number - K121907

B. 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

C. Date: June 28, 2012

D. Proprietary and Established Names:

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

E. 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

F. 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® Alkaline Phosphatase Calibrator (ALPI CAL) is the Dimension Vista® Alkaline Phosphatase Calibrator previously cleared under K061818.

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

G. Device Description:

ALP p-NP + AMP + PO4 p-NPP + AMP pH 10.25 Mg/Zn

Level	Alkaline Phosphatase U/L
1	0
2	500
3	1000

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.

H. Intended Use:

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

I. Indication(s) for Use:

Same as Intended Use

J. Substantial Equivalence Information:

Both the Dimension® 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:

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

Feature	Dimension® Alkaline PhosphataseFlex® reagent cartridge (DF150)	Predicate: ADVIA® ChemistryAlkaline Phosphatase AMPK991576
Intended Use	The ALPI method is an in vitrodiagnostic test for the quantitativemeasurement of alkaline phosphatasein human serum and plasma on theDimension® clinical chemistrysystem. Measurements of alkalinephosphatase or its isoenzymes are usedin the diagnosis and treatment of liver,bone, parathyroid, and intestinaldiseases.	For in vitro diagnostic use in thequantitative determination ofalkaline phosphatase in humanserum and plasma on the ADVIA®Chemistry systems. Suchmeasurements are used in thediagnosis and treatment ofhepatobiliary and bone disease.
Sample Type	Serum and Lithium Heparin Plasma	Serum and Lithium Heparin Plasma
Measurement	Bichromatic rate	Rate (RRA)

Similarities for Dimension® ALPI assay:

Differences for Dimension® ALPI assay:

Feature	Dimension® Alkaline PhosphataseFlex® reagent cartridge (DF150)	Predicate: ADVIA®CHEMISTRY® AlkalinePhosphatase AMP Method K991576
MeasuringRange	10 - 1000 U/L	0 - 1100 U/L
Sample Size	7 µL	3 µL

Similarities for Dimension® ALPI Calibrator

Feature	Dimension® Alkaline PhosphataseCalibrator ALPI CAL (DC150)	Predicate: Dimension Vista®Alkaline Phosphatase CalibratorALP CAL (KC330) K061818
Intended Use	ALPI CAL is an in vitro diagnosticproduct for the calibration ofalkaline phosphatase (ALPI) methodon the Dimension® clinicalchemistry 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

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

Differences for Dimension® ALPI CAL

Feature	Dimension® Alkaline PhosphataseCalibrator ALPI CAL (DC150)	Predicate: Dimension Vista®Alkaline Phosphatase CalibratorALP CAL (K330) K061818
Matrix	Human serum albumin based	Bovine protein based
TargetConcentrations	Level 1:0 U/LLevel 2: 500 U/LLevel 3: 1000 U/L	Level 2: (CAL A) 1040 U/LNote: Level 1 is System Water
Traceability	IFCC reference method	Masterpool values

K. 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)

L. Performance Characteristics

The following data represent typical performance for the Dimension® clinical chemistry systems and was collected on a Dimension® RxL.

Method Comparison

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

Dimension®	Predicate	Slope	Intercept U/L	CorrelationCoefficient (r)	n
ALPI	ADVIA®ALPAMP	1.06	-0.4	0.999	116

Dimension® Alkaline Phosphatase (ALPI) vs. Predicate

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

Serum/Plasma Comparison

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

Serum vs.	Slope	Intercept U/L	Correlation Coefficient (r)	n
LithiumHeparinPlasma	1.02	-5.08	0.999	50

Reference Interval (Expected Values)

Samples were collected from 132 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: 46-116 U/L [0.77 - 1.94 ukat/L]

Precision

Precision testing was performed in accordance with CLSI EPS-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 table:

	Repeatability		Within-Lab
Samplen=80	Mean (U/L)	SD (U/L)	%CV	SD (U/L)	%CV
BioRad® Multiqual Assayed QC
Level 1	37	0.6	1.5	1.6	4.2
Level 2	157	1.0	0.6	3.7	2.3
Level 3	303	3.3	1.1	7.1	2.4
Pools
Serum Pool 1	81	1.1	1.4	1.8	2.2
Serum Pool 2	842	5.7	0.7	13.3	1.6

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

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 testing and the Limit of Detection testing on the Dimension® clinical chemistry analyzer, the analytical measurement range was determined to be 10 - 1000 U/L.

Image /page/5/Figure/2 description: The image shows a scatter plot titled "DM ALPI Linearity: Observed vs Expected". The x-axis is labeled "Expected ALP Value (U/L)" ranging from 0 to 1400, and the y-axis is labeled "Observed ALP Value (U/L)" ranging from 0 to 1400. A dashed line of best fit is plotted through the data points, and the equation of the line is given as y = 0.9868x + 9.7726, with an R-squared value of 0.9992 and a sample size of n = 9.

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

Analytical Specificity/Interferences

The ALPI method was evaluated for interference according to CLSI EP7-A2 Interference Testing in Clinical Chemistry; Approved 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]	297[4.96]	<10
		823 [13.74]	<10
Bilirubin(unconjugated)	80 mg/dL [1026 µmol/L]	300 [5.01]	<10
		834 [13.92]	<10
Bilirubin(conjugated)	80 mg/dL [1026 µmol/L]	307 [5.12]	<10
		856 [14.29]	<10
Lipemia(Intralipid®)	500 mg/dL [5 g/L]	308 [5.14]	<10
		878 [14.66]	<10
	600 mg/dL[6 g/L]	308 [5.14]	**
		878 [14.66]	**

** Lipenia ((Intralipid") at 600 mg/dL and above tripped an error flag on this method; 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 299 U/L and 842 U/L and were found not to interfere with the ALPI method when present in serum and plasma. Inaccuracies (biases) were all less than 10%. See 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:

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

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,l instrument	3 U/L
LoD	5 low level samples were testedfor 3 days, one run per day, 2replicates per run, 2 reagent lots,1 instrument	8U/L
LoQ	3 low level samples diluted withenzyme diluent were tested for 3days, one run per day, 3replicates per run, 2 reagent lots,l instrument	9 U/L

Calibrator

For opened products, once the cap is removed, assigned values are stable for 30 days when recapped immediately after use and stored at 2-8°C.

For unopened product, see the expiration date on the calibrator carton.

M. Conclusion: The Dimension® Alkaline Phosphatase (ALPI) Flex® reagent cartridge with the associated Dimension® 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.

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

Image /page/8/Picture/0 description: The image is a seal for the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Siemens Healthcare Diagnostics c/o Rose T. Marinelli P.O. Box 6101 Newark, DE 19701

JUL 2 3 2012

Re: K121907

Trade Name: Dimension® Alkaline Phosphatase (ALPI) Flex® reagent cartridge Dimension® 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: June 28, 2012 Received: June 29, 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 controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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

Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 proase note the regarding postmarket surveillance, please contact CDRH3 Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) Office of But velhance and 250.ing of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/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 Tou may obtain other generers, 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,

Courtney 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

{10}------------------------------------------------

Indications for Use Form

510(k) Number (if known): K121907

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

Indications for Use:

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) K[2190]

Page 1 of 2

{11}------------------------------------------------

Indications for Use Form

510(k) Number (if known): K121907

Device Name: Dimension® 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® clinical chemistry system.

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) K.12(90)

Page 1 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.