510(k) · Cleared
ClearedOrtho-Mune OK-Combo Control IGG2A-Fitc/IGG2A-PE Monoclonal Antibody (Murine)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Diagnostic Systems, Inc. · GKZ Counter, Differential Cell
Cleared on Mar 6, 1997 as substantially equivalent to K900078 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1990) and 4 other predicates after a 699-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Mar 6, 1997
- Review
- 699 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 1 generation to K900078 (1990). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK900078 Simultest Imk Plus (TM)Bd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- This deviceK951632 Ortho-Mune OK-Combo Control IGG2A-Fitc/IGG2A-PE Monoclonal Antibody…Ortho Diagnostic Systems, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900078 | Simultest Imk Plus (TM) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990 | — |
| 0 (this device) | K951632 | Ortho-Mune OK-Combo Control IGG2A-Fitc/IGG2A-PE Monoclonal Antibody (Murine) | Ortho Diagnostic Systems, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 4 | 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 GKZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GKZ device
- #1 K250943 Sysmex XR-Series (XR-10) Automated Hematology…score 13.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K900078 | Simultest Imk Plus (TM)Summary page 2…869-0606 FAX: (908) 218-8168 DEVICE NAME: PREDICATE: Ortho-mune™ OK-COMBO Control Simultest™ IMK Plus 18G,,-FITC/IgG2,-PE Reagent B-Control Monoclonal Antibody (Murine) (K900078) DATE: December 19, 1996 DEVICE DESCRIPTION: Ortho-mune OK-COMBO Control IgG,,-FITC/IgGa.-PE Monoclonal Antibody (Murine) is a… | 1990 |
| Kept off the family tree | K913912 | FDA’s K913912 is Verimed Perineometer Our OCR of the scanned summary read K913912, FDA’s number for Verimed Perineometer (Verimed Holdings, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Simultest CD3/CD4 (Leu-4/3a)”. Kept off the family tree. Summary page 12…s when used with Ortho-mune OK-COMBO Control has been compared to the performance of various other single color and two color reagents and : Simultest CD3/CD4 (Leu-4/3a [K913912] in the following 510(k) Premarket Notifications. t K# | Date Cleared Ortho-mune OK - COMBO CD3-FITC/CD4-PE K950568 May 13, 19… | 1992 |
| * | K950568 | Ortho-Mune OK-Combo CD3-Fitc/CD4-PE (OKT2/OKT4A) Monoclonal Antibody (Murine) Cleared while this submission was under review Summary page 12…color reagents and : Simultest CD3/CD4 (Leu-4/3a [K913912] in the following 510(k) Premarket Notifications. t K# | Date Cleared Ortho-mune OK - COMBO CD3-FITC/CD4-PE K950568 May 13, 1996 (OKT3/0OKT4A) Ortho-mune OK - COMBO CD3-FITC/CD8-PE K950482 May 10, 1996 (OKT3/OKT8) Ortho-mune OK - COMBO CD4-FI… | 1996 |
| * | K950482 | Ortho-Mune OK-Comvo CD3-Fitc/CD8-PE (Okt 3/OKT8) Monoclonal Antibody (Murine) Cleared while this submission was under review Summary page 12…ng 510(k) Premarket Notifications. t K# | Date Cleared Ortho-mune OK - COMBO CD3-FITC/CD4-PE K950568 May 13, 1996 (OKT3/0OKT4A) Ortho-mune OK - COMBO CD3-FITC/CD8-PE K950482 May 10, 1996 (OKT3/OKT8) Ortho-mune OK - COMBO CD4-FITC/CD8-PE K950625 May 13, 1996 (OKT4A/OKTS) Ortho-mune OK-COMBO CD3-FITC/… | 1996 |
| * | K950625 | Ortho-Mune OK-Combo CD40FITC/CD8-PE (OKT4A/OKT8) Monoclonal Antibody (Murine) Cleared while this submission was under review Summary page 12…COMBO CD3-FITC/CD4-PE K950568 May 13, 1996 (OKT3/0OKT4A) Ortho-mune OK - COMBO CD3-FITC/CD8-PE K950482 May 10, 1996 (OKT3/OKT8) Ortho-mune OK - COMBO CD4-FITC/CD8-PE K950625 May 13, 1996 (OKT4A/OKTS) Ortho-mune OK-COMBO CD3-FITC/CD19-PE K951100 May 13, 1996 (OKT3/0KB19A) CONCLUSION: Performance of O… | 1996 |
| * | K951100 | Ortho-Mune OK-Combo CD3-Fitc/CD19-PE (OKT3/OKB19A Monolclonal Antibody (Murine) Cleared while this submission was under review Summary page 12…- COMBO CD3-FITC/CD8-PE K950482 May 10, 1996 (OKT3/OKT8) Ortho-mune OK - COMBO CD4-FITC/CD8-PE K950625 May 13, 1996 (OKT4A/OKTS) Ortho-mune OK-COMBO CD3-FITC/CD19-PE K951100 May 13, 1996 (OKT3/0KB19A) CONCLUSION: Performance of Ortho-mune OK-COMBO Control IgGy,-FITC/IgG.,-PE Monoclonal Antibody (Muri… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 5 ancestors has a recall.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GKZ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GKZ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GKZ
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · GKZ
77in 2025
MAUDE reports naming product code GKZ, 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 | 6 | 117 | 37 | 268 |
| 2008 | 6 | 99 | 5 | 925 |
| 2009 | 6 | 147 | 13 | 559 |
| 2010 | 4 | 290 | 27 | 896 |
| 2011 | 3 | 315 | 28 | 2,905 |
| 2012 | 3 | 408 | 7 | 2,959 |
| 2013 | 1 | — | 6 | 3,070 |
| 2014 | 3 | 165 | 0 | 3,112 |
| 2015 | 3 | 273 | 3 | 1,972 |
| 2016 | 3 | 198 | 3 | 3,338 |
| 2017 | 4 | 280 | 3 | 229 |
| 2018 | 3 | 270 | 2 (2) | 497 |
| 2019 | 5 | 210 | 2 | 908 |
| 2020 | 1 | — | 1 | 342 |
| 2021 | 0 | — | 0 | 391 |
| 2022 | 3 | 638 | 4 | 198 |
| 2023 | 4 | 329 | 1 | 155 |
| 2024 | 3 | 157 | 0 | 115 |
| 2025 | 4 | 108 | 1 | 77 |
| 2026 | 4 | 254 | 0 | — |
What is it indicated for?
Ortho-mune OK-COMBO Control is intended for use as negative control for immunophenotying of human lymphocytes in whole blood by flow cytometry using Ortho-mune OK-COMBO immunophenotyping reagents. Ortho-mune OK-COMBO immunophenotyping reagents are blends of two purified monoclonal antibodies conjugated to fluorescein isothiocyanate and phycoerythrin, respectively. The negative control is used to check for nonspecific background staining and to set the negative/positive rergions of the fluorescent cytograms.
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/K951632 · printed Nov 5, 2026
Cite this page
510(k) Report. “K951632: Ortho-Mune OK-Combo Control IGG2A-Fitc/IGG2A-PE Monoclonal Antibody (Murine).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K951632
Report an extraction error
Are you the manufacturer?
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