Alkaline Phosphatase

K240468 · Abbott Laboratories Diagnostics Division · CJE · Oct 16, 2024 · Clinical Chemistry

Device Facts

• Record ID: K240468
• Device Name: Alkaline Phosphatase
• Applicant: Abbott Laboratories Diagnostics Division
• Product Code: CJE · Clinical Chemistry
• Decision Date: Oct 16, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1050
• Device Class: Class 2

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.

Device Story

In vitro diagnostic assay for quantitative measurement of alkaline phosphatase in human serum/plasma; performed on ARCHITECT c Systems. Modifications include: addition of lithium heparin separator tubes; adjustment of on-board stability (13 to 8 days); addition of Proclin 300/950 to R2 reagent; updated sample volume parameters; addition of manual dilution procedure; optional IFCC-based calibration factor. Device used in clinical laboratory settings by trained personnel. Output provides quantitative enzyme levels to assist clinicians in diagnosing/monitoring liver, bone, and related metabolic disorders.

Clinical Evidence

Bench testing only. Verification studies confirmed the assay met pre-defined product requirements. Performance evaluated using optional IFCC calibration factor (2290) on ARCHITECT c System. Bias analysis showed a 6.5% shift in results compared to the predicate, which is within the +/-10% acceptable bias specification.

Technological Characteristics

In vitro diagnostic reagent system for clinical chemistry analyzers. Includes R2 reagent with Proclin 300 and Proclin 950 preservatives. Supports lithium heparin separator tubes. Parameters include sample volume adjustments and manual dilution procedures. Calibration supports IFCC-based factors. Operates on ARCHITECT c Systems.

Indications for Use

Indicated for the quantitative determination of alkaline phosphatase in human serum and plasma to aid in the diagnosis and treatment of liver, bone, and other diseases involving alkaline phosphatase.

Regulatory Classification

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.

Predicate Devices

• Alkaline Phosphatase (K023807)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K240468

B Applicant

Abbott Laboratories Diagnostics Division

C Proprietary and Established Names

Alkaline Phosphatase

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| CJE | Class II | 21 CFR 862.1050 - Alkaline Phosphatase Or Isoenzymes Test System | CH - Clinical Chemistry |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device: K023807, Alkaline Phosphatase.
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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3. A description of the device **MODIFICATION(S)**, including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the **FUNDAMENTAL SCIENTIFIC TECHNOLOGY** of the modified device has not changed. The modifications are:

- The addition of lithium heparin separator tubes as a claimed tube-type.
- The on-board stability claim changed from 13 days to 8 days.
- The addition of Proclin 300 and Proclin 950 to the R2 reagent formulation.
- Changes in the assay parameters for sample volume.
- The addition of a manual dilution claim to the assay specimen dilution procedures.
- Adding the option to use an International Federation of Clinical Chemistry (IFCC) based calibration factor.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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