(50 days)
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No
The description details a colorimetric assay and manual calculation, with no mention of AI or ML terms or concepts.
No.
This device is an in vitro diagnostic device used to measure substances in human serum, not to directly treat or diagnose a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states "The Bayer ADVIA 1650 Acid Phosphatase assay is an in vitro diagnostic device".
No
The device description clearly indicates it is an in vitro diagnostic assay that measures chemical concentrations in human serum using a colorimetric procedure. This involves physical reagents and laboratory equipment, not just software.
Yes, the provided text explicitly states that the Bayer ADVIA 1650 Acid Phosphatase assay is an in vitro diagnostic device.
The "Intended Use / Indications for Use" section clearly defines it as such:
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.
N/A
Intended Use / Indications for 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.
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.
Product codes
CKB; JIX; JJY
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Imprecision:
TOTAL ACP:
Level (U/L): 18.39, Within Run CV (%): 3.0, Total CV (%): 9.2
Level (U/L): 36.98, Within Run CV (%): 2.2, Total CV (%): 4.0
Level (U/L): 42.23, Within Run CV (%): 1.9, Total CV (%): 3.8
NpACP:
Level (U/L): 10.01, Within Run CV (%): 6.2, Total CV (%): 9.2
Level (U/L): 24.50, Within Run CV (%): 3.4, Total CV (%): 4.8
Level (U/L): 28.88, Within Run CV (%): 5.1, Total CV (%): 7.0
Correlation: The performance of this method (Y) was compared to the Roche Acid Phosphatase method on the Hitachi system (X).
NpACP, Specimen type: Serum, Comparison System (X): Hitachi, N: 64, Regression Equation: 0.82 x +1.8, Syx (mg/dL): 2.56, R: 0.987, Sample Range (mg/dL): 6.56 to 98.58
Total ACP, Specimen type: Serum, Comparison System (X): Hitachi, N: 71, Regression Equation: 0.76 x +0.91, Syx (mg/dL): 1.95, R: 0.993, Sample Range (mg/dL): 4.98 to 106.4
95% confidence level for slope: NpACP: 0.787 to 0.856, ACP: 0.7345-0.7781
95% confidence level for intercept: NpACP: 0.793 to 2.811, ACP: 0.189-1.627
Interfering Substances:
Interfering Substance: Bilirubin (unconjugated), Interfering Sub. Conc. (mg/dL): 6.25, ACP Conc (U/L): 17.19, Effect (% change): -9.3
Interfering Substance: Bilirubin (conjugated), Interfering Sub. Conc. (mg/dL): 6.25, ACP Conc (U/L): 18.42, Effect (% change): -1.7
Interfering Substance: Hemoglobin, Interfering Sub. Conc. (mg/dL): 50, ACP Conc (U/L): 11.44, Effect (% change): -8.8
Interfering Substance: Lipids (Triglycerides), Interfering Sub. Conc. (mg/dL): 1000, ACP Conc (U/L): 17.23, Effect (% change): +4.49
Analytical Range: 4 to 200 U/L Serum
Minimum Detectable Concentration (MDC): Determined from the total standard deviation for water obtained from the Precision study – 11 day, 22 runs, and 44 replicates.
total ACP = 1.98 U/L
npACP = 2.22 U/L
Key Metrics
Imprecision (Within Run CV, Total CV), Correlation (R), Slope, Intercept, Effect of Interfering Substances, Analytical Range, Minimum Detectable Concentration.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 Acid | ||
| Phosphatase | 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.
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.
1
Imprecision
TOTAL ACP :
| ADVIA 1650 | ||
|---|---|---|
| Level | ||
| (U/L) | Within | |
| Run CV | ||
| (%) | Total | |
| CV(%) | ||
| 18.39 | 3.0 | 9.2 |
| 36.98 | 2.2 | 4.0 |
| 42.23 | 1.9 | 3.8 |
NpACP:
| ADVIA 1650 | ||
|---|---|---|
| Level | ||
| (U/L) | Within | |
| Run CV | ||
| (%) | Total | |
| CV(%) | ||
| 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
| Interfering
Substance | 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
2
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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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) |