Alkaline Phosphatase Isoenzyme System

No FDA recalls on record, checked 5 Oct 2026.

510(k) Number

K885024 ↗

FDA Product Code

CIN

Device Class

Class II

Regulation

21 CFR Part 862.1050

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Ciba Corning Diagnostics Corp. →

• What is the Alkaline Phosphatase Isoenzyme System used for?

  This system is designed to separate and quantify alkaline phosphatase isoenzymes in serum or plasma samples. Isoenzymes are enzyme variants linked to specific tissues, such as the liver, bone, parathyroid, or intestine. By distinguishing between these isoenzyme patterns, clinicians can help differentiate conditions affecting these organs, improving diagnostic accuracy for conditions like metabolic bone disease, liver dysfunction, or gastrointestinal disorders.

• How is the Alkaline Phosphatase Isoenzyme System supplied and intended for use?

  The system is supplied as a traditional 510(k)-cleared device under FDA authorization (K885024) and is intended exclusively for single-use applications in clinical chemistry laboratories. It is not reusable and must be handled according to manufacturer guidelines to ensure accurate and reliable results.

• Is the system sterile, and what storage requirements apply?

  The Alkaline Phosphatase Isoenzyme System is not explicitly described as sterile in the provided data, but it is intended for single-use in clinical settings. Proper storage and handling are critical to maintain its integrity and performance. Users should follow the manufacturer’s guidelines for storage conditions, which likely include protection from extreme temperatures, moisture, and contamination.

• Are there any safety concerns related to MRI use with this device?

  The provided data does not mention any specific MRI safety considerations for this system. However, since it is a single-use clinical chemistry device, it is not designed for use in MRI environments. Clinicians should confirm compatibility with their facility’s MRI protocols if applicable, though this device is not intended for such settings.

• What regulatory pathway does this device follow, and what does that mean for users?

  This system is regulated under the FDA’s 510(k) pathway, specifically classified as substantially equivalent (SESE) to a predicate device. This means it has been reviewed and cleared as a Class II medical device for use in clinical chemistry laboratories. The clearance ensures compliance with diagnostic standards, but users should always refer to the manufacturer’s instructions for proper operation and maintenance.