BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)

• K Number: K012340
• Device Name: BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)
• Manufacturer: BAYER CORP.
• Date Cleared: 2001-10-01 ( 69 days)
• Product Code: JMO
• Regulation Number: 862.1415
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

The ADVIA IMS Unsaturated Iron Binding Capacity (UIBC) assay is an in vitro diagnostic device intended to measure iron binding capacity in human serum and dlagmostly are new inding capacity are used in the diagnosis and treatment of anemias.

Device Description

Not Found

AI/ML Overview

The provided document describes a 510(k) summary for a new in vitro diagnostic device, the ADVIA® IMS™ Unsaturated Iron Binding Capacity (UIBC) method. The summary focuses on demonstrating substantial equivalence to a predicate device, the Technicon CHEM 1. Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state formal "acceptance criteria" in terms of predefined success thresholds (e.g., "CV must be

Regulation Number and Section

§ 862.1415 Iron-binding capacity test system.

(a)
Identification. An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.(b)
Classification. Class I (general 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.