510(k) Report

510(k) · Cleared

Recalled · Class III · 2011

G7 Automated HPLC Analyzer, Beta-Thalassemia Mode

K020489510(k) TraditionalCleared May 14, 200290-day reviewClass II21 CFR 864.7400Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Tosoh Medics, Inc. · JPD Hemoglobin A2 Quantitation

Cleared on May 14, 2002 as substantially equivalent to K823870 (Helena Laboratories, 1983) and 2 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1980. It has been recalled 2 times.

Decided
May 14, 2002
Review
90 days
Class
Class II
Product code
JPD
Recalls
2
Predicates
3

Its longest line of descent runs back 1 generation to K802821 (1980). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1993: 1 other ancestor1983: 1 other ancestorK802821 · Paragon Hemoglobin Electro. Reag. Kit · Beckman Instruments, Inc. · 198019801985199019952000
Other ancestors, by generation 1 generation back: 2 other ancestors K802821 · Paragon Hemoglobin Electro. Reag. Kit · Beckman Instruments, Inc. · 19800
  1. Root · 1 generation backK802821 Paragon Hemoglobin Electro. Reag. KitBeckman Instruments, Inc. · 1980
  2. This deviceK020489 G7 Automated HPLC Analyzer, Beta-Thalassemia ModeTosoh Medics, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K802821Paragon Hemoglobin Electro. Reag. KitBeckman Instruments, Inc.1980—
0 (this device)K020489G7 Automated HPLC Analyzer, Beta-Thalassemia ModeTosoh Medics, Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
199310
FIG. 1 — Lineage of K020489, 1980–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JPD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K823870Beta Thalquik Column #5341
Summary page 1
…ated HPLC Analyzer: Beta- thalassemia Mode Class Il, JPD 21 CFR 864.7400 Hemoglobin A2 quantitation HbA2: Beta-Thal HbA2 Quik Column™ Helena Laboratories Beaumont, TX K823870 HbF: VARIANT BETA-THALASSEMIA SHORT PROGRAM Bio-Rad Laboratories Hercules, CA K924122 Presumptive Hb identification: Beckma…
Helena Laboratories1983—
*K924122Variant Beta-Thalassemia Short Program
Summary page 1
…antitation HbA2: Beta-Thal HbA2 Quik Column™ Helena Laboratories Beaumont, TX K823870 HbF: VARIANT BETA-THALASSEMIA SHORT PROGRAM Bio-Rad Laboratories Hercules, CA K924122 Presumptive Hb identification: Beckman Paragon® Electrophoresis Beckman Instruments, Inc. Fullerton, CA K802821 0110 347 Oys…
Bio-Rad19933
*K802821Paragon Hemoglobin Electro. Reag. Kit
Summary page 1
…MIA SHORT PROGRAM Bio-Rad Laboratories Hercules, CA K924122 Presumptive Hb identification: Beckman Paragon® Electrophoresis Beckman Instruments, Inc. Fullerton, CA K802821 0110 347 Oyster Point Blvd., Suite 201, South San Francisco, California 94080 Tel: 650/615-4970 Toll Free: 1-800/248-6764 Fax:…
Beckman Instruments, Inc.1980—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 25, 2011Not classifiedZ-3030-2011Process controlThe 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 is +/- 0.3%.
Aug 18, 2010Class IIIZ-1075-2013Component change controlThe 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 in whole blood. The firm received…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 3 ancestors has a recall of any class.

How does its category compare?

All JPD devices

JPD Hemoglobin A2 Quantitation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JPD

FDA has decided no JPD device since 2007.

Median 510(k) review, days · JPD

Too few JPD 510(k)s in any year since 2007 to give a median.

Recalls per year · JPD

1in 2011

2008: 22011: 1
2007high 2 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JPD

No MAUDE report names JPD since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—20
20090—00
20100—00
20110—10
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Tosoh Medics, Inc.

41 FDA decisions under this applicant name. See the company

  • K023893ST Aia-Pack Cea Enzyme ImmunoassayTosoh Medics, Inc. · 20021 recall
  • K023894ST Aia-Pack Afp Enzyme ImmunoassayTosoh Medics, Inc. · 20021 recall
  • K023091ST Aia-Pack Testosterone AssayTosoh Medics, Inc. · 20023 recalls
  • K023891ST Aia-Pack CA 125 Enzyme ImmunoassayTosoh Medics, Inc. · 2002
  • K012820Aia-Pack Ctni 2ND-Gen AssayTosoh Medics, Inc. · 20011 recall

Recent decisions in JPD

The JPD category page

  • K991127Variant II B-ThalassemiaBio-Rad · 19994 recalls
  • K924122Variant Beta-Thalassemia Short ProgramBio-Rad · 19933 recalls
  • K924496Glycomat Green HBA2 Estimation Reagent KitDrew Scientific, Ltd. · 1992
  • K923318Columnmate Beta-Thal HBA2 Control - NormalHelena Laboratories · 1992
  • K923317Columnmate Beta Thal HBA2 Control-AbnormalHelena Laboratories · 1992

https://510kreport.com/device/K020489 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020489: G7 Automated HPLC Analyzer, Beta-Thalassemia Mode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020489

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026