The Bayer ADVIA 1650 Acid Phosphatase assay is an in vitro diagnostic device intended to measure total and non-prostatic acid phosphatase concentrations in human serum.
The Bayer ADVIA 1650 Acid Phosphatase assay is an in vitro diagnostic device intended to quantitatively measure total and non-prostatic acid phosphatase concentration in human serum.

Device Description

The ADVIA 1650 acid phosphatase method measures total and non-prostatic acid phosphatase in serum by a colorimetric procedure published by Hillmann. Tartrate inhibits prostatic acid phosphatase, allowing for measurement of non-prostatic acid phosphatase. The prostatic acid phosphatase concentration can be manually calculated by determining the difference between total acid phosphatase and non-prostatic acid phosphatase.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Bayer ADVIA® 1650™ Acid Phosphatase assay, based on the provided text:

Acceptance Criteria and Device Performance

Parameter	Acceptance Criteria (Implicit)	Reported Device Performance
Imprecision (Total ACP)	Sufficiently low CV to ensure reliable results (no explicit criteria stated, but expected to be within industry standards for clinical assays).	Level 1 (18.39 U/L): Within-Run CV: 3.0%, Total CV: 9.2% Level 2 (36.98 U/L): Within-Run CV: 2.2%, Total CV: 4.0% Level 3 (42.23 U/L): Within-Run CV: 1.9%, Total CV: 3.8%
Imprecision (NpACP)	Sufficiently low CV to ensure reliable results (no explicit criteria stated).	Level 1 (10.01 U/L): Within-Run CV: 6.2%, Total CV: 9.2% Level 2 (24.50 U/L): Within-Run CV: 3.4%, Total CV: 4.8% Level 3 (28.88 U/L): Within-Run CV: 5.1%, Total CV: 7.0%
Correlation (NpACP)	Strong correlation with predicate device (e.g., R-value > 0.95, slope near 1, intercept near 0, given the stated bias).	N = 64, Regression Equation: Y = 0.82x + 1.8, Syx = 2.56, R = 0.987. 95% CI for slope: 0.787 to 0.856 95% CI for intercept: 0.793 to 2.811
Correlation (Total ACP)	Strong correlation with predicate device (e.g., R-value > 0.95, slope near 1, intercept near 0, given the stated bias).	N = 71, Regression Equation: Y = 0.76x + 0.91, Syx = 1.95, R = 0.993. 95% CI for slope: 0.7345 to 0.7781 95% CI for intercept: 0.189 to 1.627
Interfering Substances	Insignificant interference (e.g., % change within an acceptable clinical limit, typically < +/- 10% or clinically insignificant).	Bilirubin (unconjugated, 6.25 mg/dL): -9.3% Bilirubin (conjugated, 6.25 mg/dL): -1.7% Hemoglobin (50 mg/dL): -8.8% Lipids (Triglycerides, 1000 mg/dL): +4.49%
Analytical Range	Clearly defined and clinically useful range.	4 to 200 U/L Serum
Minimum Detectable Concentration (MDC)	Low enough for clinical utility and reporting (no explicit threshold, but expected to be below the analytical range).	Total ACP = 1.98 U/L npACP = 2.22 U/L

Note regarding Acceptance Criteria: The document does not explicitly state numerical acceptance criteria for most of these parameters. However, in the context of a 510(k) submission, the "acceptance criteria" are implicitly met if the reported performance is demonstrated to be "substantially equivalent" to predicate devices and acceptable for the intended use in a clinical laboratory setting. The FDA's issuance of the 510(k) implies that the provided data was deemed acceptable.

Study Details

Sample sizes used for the test set and the data provenance:
- Correlation (NpACP): N = 64 serum samples.
- Correlation (Total ACP): N = 71 serum samples.
- Imprecision: Not explicitly stated as a "test set" in the same way as correlation. Imprecision studies typically involve repeated measurements of control materials or pooled patient samples over several days. For MDC, 44 replicates over 11 days (22 runs) were used.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This information is typically detailed in the full study report, but is not present in this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This device is an in vitro diagnostic assay for measuring biomarkers, not an image-based or diagnostic interpretation device requiring expert review for ground truth. The "ground truth" for method comparison and imprecision studies relies on the established reference method (the predicate device for correlation) and the inherent chemical properties of the analytes. Therefore, this question is not directly applicable in the same way as it would be for AI-powered diagnostic tools. There would be no "experts" establishing ground truth in this context.
Adjudication method for the test set:
- Not applicable. As this is a quantitative chemical assay, the "adjudication" (if one could use that term) is based on the result from the predicate device and standard analytical chemistry principles, not expert consensus or review.
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:
- Not applicable. This is a standalone in vitro diagnostic assay, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, this entire submission describes the standalone performance of the ADVIA 1650 Acid Phosphatase assay as a laboratory instrument. The performance metrics (imprecision, correlation, interference, analytical range, MDC) are all measures of the device's inherent analytical capabilities.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the correlation study, the "ground truth" was established by the predicate device (Roche Acid Phosphatase method on the Hitachi system). The ADVIA 1650's results were compared against this established method.
- For imprecision, analytical range, and MDC, the "ground truth" is derived from standard analytical chemistry and metrology principles, using reference materials, control solutions, and repeated measurements.
The sample size for the training set:
- Not applicable. As an in vitro diagnostic assay using established chemical reactions (Hillmann colorimetric procedure), there is no 'training set' in the machine learning sense. The method's parameters are based on scientific principles and validated through the studies presented.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of IVD device.

Summary

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JAN 0 7 2003

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Acid Phosphatase method for ADVIA® 1650™

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

The assigned 510(k) number is: Ka23840

1. Intended Use

The Bayer ADVIA 1650 Acid Phosphatase assay is an in vitro diagnostic device intended to measure total and non-prostatic acid phosphatase concentrations in human serum.

2. Predicate Device

Product Name	Reagent Part #	Calibrator Part #
Roche ACP	1553437	759350

3. Device / Method

Product Name	Reagent BAN	Calibrator BAN
Bayer ADVIA® 1650TM AcidPhosphatase	B01-4803-01	B03-4821-01

SUMMARY AND EXPLANATION

Acid phosphatase includes all phosphatases with optimal activity below a pH of 7.0. The greatest concentrations of acid phosphatases are found in human in liver, spleen, milk, erythrocytes, platelets, bone marrow, and prostate gland. Prostatic acid phosphatase is found primarily in the prostate and is tartrate-sensitive. In normal males, prostatic acid phosphatase accounts for about 50% of the serum total acid phosphatase. Enzymatic activity of prostatic acid phosphatase is found elevated in sera of about 60% of men with metastatic prostate cancer. But for carcinomas confined in the prostate gland, the enzyme activity can be normal or only slightly increased. Transient increase in prostatic acid phosphatase can occur after prostate surgery. biopsy, manipulation or catherization, and in the presence of benign prostate hypertrophy, prostatitis and prostate infarction. Serum total acid phosphatase levels, on the other hand, can be elevated in other diseases and conditions such as Paget's disease, hyperparathyroidism with skeletal involvement, cancer metastases to the bone, Gaucher's disease. Niemann-Pick disease and myelocytic leukemia.

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Imprecision

TOTAL ACP :

ADVIA 1650
Level(U/L)	WithinRun CV(%)	TotalCV(%)
18.39	3.0	9.2
36.98	2.2	4.0
42.23	1.9	3.8

NpACP:

ADVIA 1650
Level(U/L)	WithinRun CV(%)	TotalCV(%)
10.01	6.2	9.2
24.50	3.4	4.8
28.88	5.1	7.0

Correlation (Y=ADVIA 1650, X=comparison system)

The performance of this method (Y) was compared to the Roche Acid Phosphatase method on the Hitachi system (X). The previously marketed device to which the ADVIA 1650 is compared, uses 1,5 pentanediol. This may be the reason for the observed bias between the two (2) devices.

Method	Specimen type	Comparison System (X)	N	Regression Equation	Syx (mg/dL)	R	Sample Range (mg/dL)
NpACP	Serum	Hitachi	64	$0.82 x +1.8$	2.56	0.987	6.56 to 98.58
Total ACP	Serum	Hitachi	71	$0.76 x +0.91$	1.95	0.993	4.98 to 106.4

	NpACP	ACP
95% confidence level for slope:	0.787 to 0.856	0.7345-0.7781
95% confidence level for intercept:	0.793 to 2.811	0.189-1.627

Interfering Substances

InterferingSubstance	Interfering Sub.Conc. (mg/dL)	ACP Conc(U/L)	Effect(% change)
Bilirubin (unconjugated)	6.25	17.19	-9.3
Bilirubin (conjugated)	6.25	18.42	-1.7
Hemoglobin	50	11.44	-8.8
Lipids (Triglycerides)	1000	17.23	+4.49

Analytical Range

4 to 200 U/L Serum

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Minimum Detectable Concentration

Minimum Detectable Concentration (MDC) was determined from the total standard deviation for water obtained from the Precision study – 11 day, 22 runs, and 44 replicates. The concentration equivalent to Mean+2SD for such samples gave the following MDC: total ACP = 1.98 U/L, npACP = 2.22 U/L.

Andres Holle Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097 Date

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle head in profile, with three lines representing the feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle head. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 0 7 2003

Mr. Andres Holle Regulatory Affairs Manager Bayer Diagnostics Corporation 511 Benedict Avenue Tarrytown, NY 10591-5097

Re: K023840

Trade/Device Name: Acid Phosphatase Assay for the ADVIA® 1650™ Regulation Number: 21 CFR 862.1020 Regulation Name: Acid Phosphatase test system Regulatory Class: Class II Product Code: CKB; JIX; JJY Dated: December 23, 2002 Received: December 24, 2002

Dear Mr. Holle:

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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). Other general information on your responsibilities under the Act may be obtained 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 yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Page _1_of _1

510(k) Number: ¥っ23840

Device Name: Acid Phosphatase Assay for the ADVIA® 1650™

Indications for Use:

The Bayer ADVIA 1650 Acid Phosphatase assay is an in vitro diagnostic device intended to quantitatively measure total and non-prostatic acid phosphatase concentration in human serum.

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)

	(Division Sign-Off)
	Division of Clinical Laboratory Devices
	510(k) Number_________________________________________________________________________________________________________________________________________________________________


Prescription Use	OR	Over-The-CounterUse
(Per 21 CFR 801.109)		(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1020 Acid phosphatase (total or prostatic) test system.

(a)
Identification. An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in plasma and serum.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.