510(k) Report

510(k) · Cleared

Recalled · 2011

Variant Beta-Thalassemia Short Program

K924122510(k) TraditionalCleared Mar 11, 1993209-day reviewClass II21 CFR 864.7400Recalls 3

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

Bio-Rad · JPD Hemoglobin A2 Quantitation

Cleared on Mar 11, 1993 after a 209-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it. It has been recalled 3 times.

Decided
Mar 11, 1993
Review
209 days
Class
Class II
Product code
JPD
Recalls
3
Predicates
0

7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2002: 1 descendant cleared2004: 1 descendant cleared2006: 2 descendants cleared2023: 1 descendant cleared2013: 1 descendant cleared1990200020102020
  1. This deviceK924122 Variant Beta-Thalassemia Short ProgramBio-Rad · 1993
  2. Descendant · cites it directly · 5 of its ownK991127 Variant II B-ThalassemiaBio-Rad · 1999 · Recalled
  3. Descendant · 2 generations on · 1 of its ownK063643 Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia…Bio-Rad Laboratories Inc., Clinical Systems Divisi · 2006 · Recalled
  4. Descendant · 2 generations on · 1 of its ownK041444 Bio-Rad D-10 Dual ProgramBio-Rad Laboratories, Inc. · 2004 · Recalled
  5. Descendant · 2 generations on · 0 of its ownK222635 Premier Resolution SystemTrinity Biotech (Primus Corporation, Dba Trinity Biotech) · 2023
  6. Descendant · 3 generations on · 0 of its ownK130860 Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin…Bio-Rad Laboratories, Inc., Clinical Systems Divis · 2013

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

1999: 12002: 12004: 12006: 22013: 12023: 1
1999high 2 (2006) · low 0 (2000)2026

Most influential descendants

Showing 5 of 7 · See all
  • K991127Variant II B-ThalassemiaBio-Rad · 1999 · cites it directly5descendants
  • K063643Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short Program and…Bio-Rad Laboratories Inc., Clinical Systems Divisi · 2006 · 2 generations on1descendant
  • K041444Bio-Rad D-10 Dual ProgramBio-Rad Laboratories, Inc. · 2004 · 2 generations on1descendant
  • K222635Premier Resolution SystemTrinity Biotech (Primus Corporation, Dba Trinity Biotech) · 2023 · 2 generations on0descendants
  • K130860Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin Testing System with CDM…Bio-Rad Laboratories, Inc., Clinical Systems Divis · 2013 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K924122Variant Beta-Thalassemia Short ProgramBio-Rad1993—
+1K991127Variant II B-ThalassemiaBio-Rad19994
+2K063643Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short…Bio-Rad Laboratories Inc., Clinical Systems Divisi20061
+2K041444Bio-Rad D-10 Dual ProgramBio-Rad Laboratories, Inc.20042
+2K222635Premier Resolution SystemTrinity Biotech (Primus Corporation, Dba Trinity Biotech)2023—
+3K130860Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin Testing System…Bio-Rad Laboratories, Inc., Clinical Systems Divis2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200210
200410
200620
201310
202310
FIG. 1 — Lineage of K924122, 1993–2023Source: 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), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K991127Variant II B-ThalassemiaBio-Rad19995
K020489G7 Automated HPLC Analyzer, Beta-Thalassemia ModeTosoh Medics, Inc.20020

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 12, 2011Not classifiedZ-0025-2012Process controlA previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these…
Mar 18, 2008Not classifiedZ-1589-2008Mixed-up of materials/componentsSome product ROM cards have an incorrect program loaded and are unable to be updated.
Mar 18, 2008Not classifiedZ-1588-2008Mixed-up of materials/componentsSome product ROM cards have an incorrect program loaded and are unable to be updated.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K991127 (Bio-Rad, 1999) has gone furthest, with 5 descendants of its own.

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—

More from Bio-Rad

322 FDA decisions under this applicant name. See the company

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Recent decisions in JPD

The JPD category page

  • K020489G7 Automated HPLC Analyzer, Beta-Thalassemia ModeTosoh Medics, Inc. · 20022 recalls
  • K991127Variant II B-ThalassemiaBio-Rad · 19994 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/K924122 · printed Nov 6, 2026

Cite this page

510(k) Report. “K924122: Variant Beta-Thalassemia Short Program.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924122

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026