# K020489: G7 Automated HPLC Analyzer, Beta-Thalassemia Mode

- Pathway: 510(k) (Traditional)
- Applicant: Tosoh Medics, Inc.
- Decided: May 14, 2002 after 90 days
- Product code: JPD (Hemoglobin A2 Quantitation)
- Device class: 2
- Regulation: 21 CFR 864.7400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K802821 (1980). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K823870: Beta Thalquik Column #5341, Helena Laboratories (1983) Summary page 1.
- K924122: Variant Beta-Thalassemia Short Program, Bio-Rad (1993) Summary page 1.
- K802821: Paragon Hemoglobin Electro. Reag. Kit, Beckman Instruments, Inc. (1980) Summary page 1.

## Recalls of this device
- May 25, 2011 · Not classified · Z-3030-2011: The value after reconstitution appeared to be lower than the assigned value on the label. The measured value for Lot BCAL05R was 5.3%, whereas the value on the label is 5.7%. The criteria of the value
- Aug 18, 2010 · Class III · Z-1075-2013: The Beta-thalessemia Mode of the G7 Analyzer-Beta Thalassemia Mode is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports HbF and HbA2 quantitative percentages

## Indications for use
The G7 Automated HPLC Analyzer: Beta-thalassemia Mode is intended for IN VITRO DIAGNOSTIC USE ONLY for the separation and area percent determinations of hemoglobins A2 and F and as an aid in the detection and presumptive identification of abnormal hemoglobins in whole biood using ion-exchange high performance liquid chromatography (HPLC). The G7 Automated HPLC Analyzer: Beta-thalassemia Mode reagents and software are intended only for use on the Tosoh G7 Automated HPLC Analyzer.

Source page: https://510kreport.com/device/K020489
Methodology: https://510kreport.com/methodology