510(k) · Cleared
ClearedR&D HGB/GLC Whole Blood Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
R&D Systems, Inc. · GGM Control, Hemoglobin
Cleared on Nov 12, 1999 as substantially equivalent to K961195 (Streck Laboratories, Inc., 1996) after a 39-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- Nov 12, 1999
- Review
- 39 days
- Class
- Class II
- Product code
- GGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K934641 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK934641 I-Stat Control Levels 1,2,3I-Stat Corp. · 1993
- 1 generation backK961195 Chem-Chex StatStreck Laboratories, Inc. · 1996
- This deviceK993321 R&D HGB/GLC Whole Blood ControlR&D Systems, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK034048 R&D Glu-Line Hematology ControlR&D Systems, Inc. · 2004
Most influential descendants
Showing 1 of 1 · See all- K034048R&D Glu-Line Hematology ControlR&D Systems, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K934641 | I-Stat Control Levels 1,2,3 | I-Stat Corp. | 1993 | — |
| −1 | K961195 | Chem-Chex Stat | Streck Laboratories, Inc. | 1996 | — |
| 0 (this device) | K993321 | R&D HGB/GLC Whole Blood Control | R&D Systems, Inc. | 1999 | — |
| +1 | K034048 | R&D Glu-Line Hematology Control | R&D Systems, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
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 GGM? 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 |
|---|---|---|---|
| * | K961195 | Chem-Chex StatSummary page 1…ontrol CFR section: Device Class: Class 11 Device to which substantial equivalence is claimed: HQ-Chex, manufactured by Streck Laboratories, Omaha, NE. 510(k) number: K961195 Intended use: R&D Glucose/Hemoglobin ™ Whole Blood Control is an assayed whole blood product for monitoring the accuracy and pre… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K034048 | R&D Glu-Line Hematology Control | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K034048 (R&D Systems, Inc., 2004) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GGM devicesGGM Control, Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GGM
2in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · GGM
Too few GGM 510(k)s in any year since 2007 to give a median.
Recalls per year · GGM
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GGM
1in 2018
MAUDE reports naming product code GGM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 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 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 2 | 1 |
| 2019 | 2 | — | 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?
R&D Glu/Hgb Control is an assayed whole blood product used to monitor the precision and accuracy of analyzers that measure glucose and hemoglobin in whole blood.
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/K993321 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993321: R&D HGB/GLC Whole Blood Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993321
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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