510(k) · Cleared
Recalled · Class II · 2018Caltag Fetal Hemoglobin Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caltag Laboratories, Inc. · GHQ Stain, Fetal Hemoglobin
Cleared on Sep 17, 1999 as substantially equivalent to K892241 (Sure-Tech Diagnostic Associates, Inc., 1989) after a 203-day review. Its family tree reaches back 1 generation to 1989. It has been recalled once.
- Decided
- Sep 17, 1999
- Review
- 203 days
- Class
- Class II
- Product code
- GHQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K892241 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK892241 Fetal HemoglobinSure-Tech Diagnostic Associates, Inc. · 1989
- This deviceK990641 Caltag Fetal Hemoglobin TestCaltag Laboratories, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K892241 | Fetal Hemoglobin | Sure-Tech Diagnostic Associates, Inc. | 1989 | — |
| 0 (this device) | K990641 | Caltag Fetal Hemoglobin Test | Caltag Laboratories, Inc. | 1999 | — |
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 GHQ? 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
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K892241 | Fetal HemoglobinSummary page 1…ANUFACTURER IS CLAIMING SUBSTANTIAL EQUIVALENCE: Caltag Fetal Hemoglobin Test is substantially equivalent to Sure-Tech Fetal Hemoglobin Test for in vitro diagnostic use (K892241), manufactured by Sure-Tech Diagnostic Associates, Inc., 11012 Un Valle, Suite D, St. Louis, Mo. 63123. -2- DESC… | 1989 |
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
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 7, 2018 | Class II | Z-1388-2018 | Use error | Three lots of Human Fetal Hemoglobin FITC Conjugate are displaying high background and unusual bright staining in the controls and patient samples which could potentially lead to erroneous results (i.e. false positives) |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All GHQ devicesGHQ Stain, Fetal Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GHQ
FDA has decided no GHQ device since 2007.
Median 510(k) review, days · GHQ
Too few GHQ 510(k)s in any year since 2007 to give a median.
Recalls per year · GHQ
No recall names GHQ since 2007.
Adverse event reports per year · GHQ
No MAUDE report names GHQ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Caltag Fetal Hemoglobin Test, containing either FITC, R-PE or TRI-COLOR® conjugated monoclonal antibodies to fetal hemoglobin (hemoglobin F), is intended for the identification followed by enumeration of fetal red blood cells. Fetal red cells are identified by the presence of fetal hemoglobin by a flow cytometric method. Fetal cells, when found in the maternal circulation, may be an indication of fetal or maternal trauma or various obstetrical…
Read the full statement (136 words)
The Caltag Fetal Hemoglobin Test, containing either FITC, R-PE or TRI-COLOR® conjugated monoclonal antibodies to fetal hemoglobin (hemoglobin F), is intended for the identification followed by enumeration of fetal red blood cells. Fetal red cells are identified by the presence of fetal hemoglobin by a flow cytometric method. Fetal cells, when found in the maternal circulation, may be an indication of fetal or maternal trauma or various obstetrical complications. The hemorrhage of Rh+ fetal blood into Rh- maternal blood may result in the formation of sensitizing Rh antibodies in the mother. Sensitization may be prevented by the administration to the mother of Rh immune globulin (RhIg) soon after delivery. The Caltag Fetal Hemoglobin Test may be used as an aid in detecting Rh incompatible fetal-maternal hemorrhage and determining the need for immunoprophylaxis with Rh immune globulin.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990641 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990641: Caltag Fetal Hemoglobin Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990641
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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