(239 days)
No
The description details a standard enzymatic assay for measuring alkaline phosphatase activity based on a colorimetric reaction, with no mention of AI or ML technologies.
No.
This device is an in vitro diagnostic (IVD) assay designed for quantitation of alkaline phosphatase. The results are used as an aid in diagnosis and treatment, which means it helps in monitoring or guiding treatment rather than directly treating a condition itself.
Yes
The device is described as an aid in the diagnosis and treatment of various diseases, and it quantifies a biomarker (alkaline phosphatase) that helps in this diagnostic process.
No
The device description clearly describes a chemical assay that measures the rate of absorbance increase at 404 nm, indicating a physical process involving reagents and a spectrophotometer, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the assay is used for the "quantitation of alkaline phosphatase in human serum or plasma." This involves testing samples taken from the human body.
- Indications for Use: The indications for use state that the measurements are used "as an aid in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases." This clearly indicates a diagnostic purpose.
- Device Description: The description details a chemical reaction that occurs in vitro (outside the body) to measure the activity of an enzyme in a biological sample.
- Predicate Device: The mention of a predicate device (K023807; Alkaline Phosphatase) which is also an IVD further supports this classification.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The Alkaline Phosphatase assay is used for the quantitation of alkaline phosphatase in human serum or plasma.
Measurements of alkaline phosphatase or its isoenzymes are to be used as an aid in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
Product codes (comma separated list FDA assigned to the subject device)
CJE
Device Description
The Alkaline Phosphatase assay is an automated clinical chemistry assay.
Alkaline phosphatase in the sample catalyzes the hydrolysis of colorless p-nitrophenyl phosphate (p-NPP) to give p-nitrophenol and inorganic phosphate. At the pH of the assay (alkaline), the p-nitrophenol is in the yellow phenoxide form. The rate of absorbance increase at 404 nm is directly proportional to the alkaline phosphatase activity in the sample. Optimized concentrations of zinc and magnesium ions are present to activate the alkaline phosphatase in the sample.
Mentions image processing
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Mentions AI, DNN, or ML
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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
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Alkaline Phosphatase assay, evaluated using the optional calibration factor of 2290 on the ARCHITECT c System, met the pre-defined product requirements for all characteristics evaluated in the verification studies.
The IFCC calibration factor (2290) represents only a mathematical factor change from the non-IFCC factor. Use of the IFCC calibration factor results in a 6.5% increase in reported results throughout the measurement range of the assay when compared to the unmodified predicate device. A shift of 6.5% is within the acceptable assay bias specifications (up to +/-10%) and thus does not have a potential to cause incorrect results. Furthermore, since the IFCC calibration factor is optional, it requires the customer to manually change the calibration factor parameter in the instrument, so the customer would be aware when they switched to using the IFCC calibration factor and would therefore be aware of the potential shift in results.
In addition to the implementation of the optional IFCC-based calibration factor, several other changes were made to the device since its clearance in 2002. Abbott performed a comprehensive risk-based assessment for each of the changes listed in the Alkaline Phosphatase Special 510(k) (K240468). The assessment includes all risks associated with each device modification, risk control measures to mitigate each identified risk, and the verification and/or validation activities required (including a summary of test methods, acceptance criteria, results, and why each is adequate to support substantial equivalence). The risk control measures show that the accumulated modifications did not impact the performance of the device. In conclusion, the modified device is therefore deemed to be substantially equivalent to the predicate device (cleared under K023807) as demonstrated by results obtained in the studies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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October 16, 2024
Abbott Laboratories Diagnostics Division Bryant Tate Manager of Regulatory Affairs 1915 Hurd Drive, Department RA11, Building LC 8 - 4th Floor MS 8-9 Irving, Texas 75038
Re: K240468
Trade/Device Name: Alkaline Phosphatase Regulation Number: 21 CFR 862.1050 Regulation Name: Alkaline Phosphatase Or Isoenzymes Test System Regulatory Class: Class II Product Code: CJE Dated: September 16, 2024 Received: September 16, 2024
Dear Bryant Tate:
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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Paula V. Caposino -S
Paula Caposino, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K240468
Device Name Alkaline Phosphatase
Indications for Use (Describe)
The Alkaline Phosphatase assay is used for the quantitation of alkaline phosphatase in human serum or plasma.
Measurements of alkaline phosphatase or its isoenzymes are to be used as an aid in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
I. 510(k) Number
II. Applicant Name
Abbott Laboratories Diagnostics Division 1915 Hurd Drive Department RA11, Building LC 8 - 4th Floor MS 8-9 Irving, TX 75038 United States
Primary contact person for all communications:
Bryant Tate, Manager of Regulatory Affairs Abbott Laboratories, Core Diagnostics bryant.tate(@abbott.com Primary Phone (214) 862-6620 Alternate Phone (972) 518-6260
Secondary contact person for all communications:
Jacek Gorzowski, Director of Regulatory Affairs Abbott Laboratories, Core Diagnostics jacek.gorzowski@abbott.com Phone (224) 668-1740
Date Summary Prepared: October 16, 2024
III. Device Name
Device Trade Name: Alkaline Phosphatase
Common Name: Alkaline phosphatase or isoenzymes test system Classification Name: Nitropheny|phosphate, Alkaline Phosphatase Or Isoenzymes Governing Regulation Number: 21 CFR §862.1050 Product Code: CJE
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IV. Legally Marketed Predicate Device
Predicate Number: K023807 Predicate Trade Name: Alkaline Phosphatase Product Code: CJE
V. Device Description Summary
The Alkaline Phosphatase assay is an automated clinical chemistry assay.
Alkaline phosphatase in the sample catalyzes the hydrolysis of colorless p-nitrophenyl phosphate (p-NPP) to give p-nitrophenol and inorganic phosphate. At the pH of the assay (alkaline), the p-nitrophenol is in the yellow phenoxide form. The rate of absorbance increase at 404 nm is directly proportional to the alkaline phosphatase activity in the sample. Optimized concentrations of zinc and magnesium ions are present to activate the alkaline phosphatase in the sample.
The kit configurations of the Alkaline Phosphatase reagent kits are described below.
| List Number | ||
|---|---|---|
| 7D55-22 | 7D55-32 | |
| Estimated tests per kit | 1,500* | 11,358* |
| Reagent 1 (R1) | 5 x 21 mL | 10 x 84 mL |
| Reagent 2 (R2) | 5 x 9 mL | 10 x 26 mL |
*Calculation is based on the minimum reagent fill volume per kit.
| Reactive Ingredients | Concentration |
|---|---|
| R1 | |
| 2-amino-2-methylpropanol | |
| Magnesium | |
| Zinc sulfate | |
| HEDTA | > 1.2 mol/L |
| > 7.2 mmol/L | |
| > 3.6 mmol/L | |
| > 7.2 mmol/L | |
| R2 | |
| 4-nitrophenyl phosphate |
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VI. Intended Use/Indications for Use
The Alkaline Phosphatase assay is used for the quantitation of alkaline phosphatase in human serum or plasma.
Measurements of alkaline phosphatase or its isoenzymes are to be used as an aid in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
VII. Technological Comparison
The similarities and differences between the subject device (Alkaline Phosphatase) and the predicate device (Alkaline Phosphatase [K023807]) are presented in the following table.
| | Subject Device:
Alkaline Phosphatase | Cleared Predicate Device:
Alkaline Phosphatase
Special 510(k) K023807 |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | Alkaline Phosphatase | |
| General Device Characteristic Similarities | | |
| Platform | ARCHITECT c8000 instrument | Same |
| Intended Use and
Indications for
Use | The Alkaline Phosphatase assay is
used for the quantitation of alkaline
phosphatase in human serum or
plasma. | Same |
| Methodology | Para-nitrophenyl phosphate | Same |
| Specimen Type | Human serum or plasma | Same |
| Assay Principle /
Principle of
Procedure | Several substrates have been used to
measure alkaline phosphatase activity
such as glycerophosphate,1 phenyl
phosphate,1 and p-nitrophenyl
phosphate.2 Bowers and McComb3
improved the method of Bessey et al.
to include a kinetic measurement.
Tietz et al.4 optimized this method to | Same |
| Characteristics | Subject Device:
Alkaline Phosphatase
include a chelated metal-ion buffer of
zinc, magnesium, and HEDTA. This
Alkaline Phosphatase procedure is a
modification of this method. Alkaline
phosphatase in the sample catalyzes
the hydrolysis of colorless
p-nitrophenyl phosphate (p-NPP) to
give p-nitrophenol and inorganic
phosphate. At the pH of the assay
(alkaline), the p-nitrophenol is in the
yellow phenoxide form. The rate of
absorbance increase at 404 nm is
directly proportional to the alkaline
phosphatase activity in the sample.
Optimized concentrations of zinc and
magnesium ions are present to activate
the alkaline phosphatase in the sample. | Cleared Predicate Device:
Alkaline Phosphatase
Special 510(k) K023807 |
| Use of Calibrators | No | Same |
| Use of Controls | Yes | Same |
| General Device Characteristic Differences | | |
| Legal
Manufacturer | Abbott GmbH & Co. KG
Max-Planck-Ring 2
65205 Wiesbaden
Germany | Abbott Laboratories
Abbott Park, IL 60064, USA |
| R2 Reagent
Formulation | Ingredients | Concentration |
| | 4-nitrophenyl phosphate | > 171.6 mmol/L |
| | Tris hydroxymethyl aminomethane
Sodium Chloride
4-Hydroxybenzoic acid
Proclin 300
Proclin 950 | 1.12%
0.001%
5.6%
0.5 g/L
1 g/L |
| Reagent Kit
Components | Reagent Kit (List Number 7D55-32)
Reagent 1 (R1) 10 x 84 mL
Reagent 2 (R2) 10 x 26 mL
Estimated tests per kit: 11,358
Reagent Kit (List Number 7D55-22) | Reagent Kit (List Number 7D55-20)
Reagent 1 (R1) 10 x 84 mL
Reagent 2 (R2) 10 x 35 mL
Estimated tests per kit:11,358
Reagent Kit (List Number 7D55-30) |
| Characteristics | Subject Device:
Alkaline Phosphatase | Cleared Predicate Device:
Alkaline Phosphatase
Special 510(k) K023807 |
| | Reagent 1 (R1) 5 x 21 mL | Reagent 1 (R1) 5 x 48 mL |
| | Reagent 2 (R2) 5 x 9 mL | Reagent 2 (R2) 5 x 22 mL |
| | Estimated tests per kit: 1,500 | Estimated tests per kit: 3,165 |
| Assay Parameters,
Assay Volume
Requirements | R1 60
R2 20
Water volume: 125 45 | R1 60
R2 20
Water volume: 170 0 |
| Lower Limits of
Measurement | Limit of Detection: 5.0 U/L
Limit of Quantitation: 5.0 U/L | Limit of Detection: 1.9 U/L
Limit of Quantitation: 5.0 U/L |
| On-Board
Stability | 8 Days | 13 Days |
| Tube Types | Serum:
- Serum tubes
- Serum separator tubes
Plasma: - Lithium heparin tubes
- Lithium heparin separator tubes
- Sodium heparin tubes | Serum:
- Serum tubes
- Serum separator tubes
Plasma: - Lithium heparin tubes
- Ammonium heparin
- Sodium heparin tubes |
| Linearity | Linear up to 2,200 U/L (2343 U/L using IFCC factor)
Flex Rate Linearity is 4555 U/L (4851 U/L using IFCC factor) | Linear up to 2200 U/L
Flex Rate Linearity up to
4555 U/L |
| Standardization | Molar extinction of p -nitrophenol (non-IFCC method)
IFCC* reference method | Molar extinction of p -nitrophenol (non-IFCC method) |
| Calibration
Method | Factor Method (calibration factor of 2150, original, or 2290, traceable to IECC) | Factor Method (calibration factor of 2150) |
1 King EJ, Armstrong AR. A convenient method for determining serum and bile phosphatase activity. Can Med Assoc J 1934;31:376-381.
2 Bessey OA, Lowry OH, Brock MJ. A method for the rapid determination of alkaline phosphatase with five cubic millimeters of serum. J Biol Chem 1946;164:321-329.
3 Bowers GN, McComb RB. A continuous spectrophotometric method for measuring the activity of serum alkaline phosphatase. Clin Chem 1966:12(2):70-89.
4 Tietz NW, Burtis CA, Duncan P, et al. A reference method for measurement of alkaline phosphatase activity in human serum. Clin Chem 1983;29(5):751-761.
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- IFCC = International Federation of Clinical Chemistry and Laboratory Medicine
VIII. Non-Clinical and/or Clinical Tests Summary & Conclusions
The Alkaline Phosphatase assay, evaluated using the optional calibration factor of 2290 on the ARCHITECT c System, met the pre-defined product requirements for all characteristics evaluated in the verification studies
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The IFCC calibration factor (2290) represents only a mathematical factor change from the non-IFCC factor. Use of the IFCC calibration factor results in a 6.5% increase in reported results throughout the measurement range of the assay when compared to the unmodified predicate device. A shift of 6.5% is within the acceptable assay bias specifications (up to +/-10%) and thus does not have a potential to cause incorrect results. Furthermore, since the IFCC calibration factor is optional, it requires the customer to manually change the calibration factor parameter in the instrument, so the customer would be aware when they switched to using the IFCC calibration factor and would therefore be aware of the potential shift in results.
In addition to the implementation of the optional IFCC-based calibration factor, several other changes were made to the device since its clearance in 2002. Abbott performed a comprehensive risk-based assessment for each of the changes listed in the Alkaline Phosphatase Special 510(k) (K240468). The assessment includes all risks associated with each device modification, risk control measures to mitigate each identified risk, and the verification and/or validation activities required (including a summary of test methods, acceptance criteria, results, and why each is adequate to support substantial equivalence). The risk control measures show that the accumulated modifications did not impact the performance of the device. In conclusion, the modified device is therefore deemed to be substantially equivalent to the predicate device (cleared under K023807) as demonstrated by results obtained in the studies.