510(k) · Cleared
ClearedNova Max Plus Glocose and B-Ketone Control Solution-Mid, High
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nova Biomedical Corp. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Aug 27, 2010 as substantially equivalent to K091547 (Nova Biomedical Corp., 2010) and 1 other predicate after a 78-day review. Its family tree reaches back 7 generations to 1995. 1 of the 15 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 27, 2010
- Review
- 78 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K945887 (1995). 14 ancestors in all, the oldest K850368 (1985). No later device cites it as a predicate yet. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 6 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- 5 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
- 4 generations backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- 3 generations backK983504 Precision Xtra Advanced Diabetes Management System, Precision Blood…Medisense, Inc. · 1999 · Recalled
- 2 generations backK040814 Modification to Precision Xtra Advanced Diabetes Management SystemAbbott Laboratories · 2004 · Recalled
- 1 generation backK091547 Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max…Nova Biomedical Corp. · 2010 · Recalled (Class I)
- This deviceK101633 Nova Max Plus Glocose and B-Ketone Control Solution-Mid, HighNova Biomedical Corp. · 2010
Class I recalls in this family
- K091547 Nova Max Plus Blood Glucose and B-Ketone Monitor…direct predicate · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −6 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| −5 | K963676 | Precision G Blood Glucose Testing System | Medisense, Inc. | 1997 | — |
| −4 | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| −3 | K983504 | Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose… | Medisense, Inc. | 1999 | 1 |
| −2 | K040814 | Modification to Precision Xtra Advanced Diabetes Management System | Abbott Laboratories | 2004 | 3 |
| −1 | K091547 | Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus… | Nova Biomedical Corp. | 2010 | Class I |
| 0 (this device) | K101633 | Nova Max Plus Glocose and B-Ketone Control Solution-Mid, High | Nova Biomedical Corp. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2007 | 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.
1 device in this family has a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | K091547 | Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control…Summary page 1…Class!I per 21 CFR 862.1435 Product Codes: JJX, SIN * Predicate Devices: Nova Max Plus Blood Glucose and B-Ketonc Monitor System, K09 1547 Nova Max Blood Glucose Monitor, K(070255 * Description of the Device: Intended Use/indications… | 2010 |
| * | K070255 | Nova Max Blood Glucose Monitor System, 90001,90002Summary page 2…Plus Blood Glucose and P-Ketone Monitor System (1K091547), and the predicate Nova Max Blood Glucose Monitor (K070255). * Performance Studies: The performance of the Nova Max Plus Glucose and P-Ketone laboratoty. Stability studies, prec… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K091547Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control Solutions, Nova Max…Nova Biomedical Corp. · 2010 · Direct predicate · ◆ on the line of descent in FIG. 110 Class I recalls
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 14 ancestors have a recall of any class; 1 has a Class I recall.
- 6 other devices also cite its predicate K091547.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, 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 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Nova Max Plus Glucose and β-Ketone Control Solutions are intended for use with the Nova Max Family of Monitors (Nova Max, Nova Max Plus, and Nova Max Link), BD Logic and Paradigm Link Monitors, Nova Max Glucose Test Strips, and Nova Max Plus Ketone Test Strips as a quality control check to verify the accuracy of blood Glucose and β-Ketone test results. There are two levels of Nova Max Plus Glucose and β-Ketone Control Solutions (Mid and High).
Nova Max Plus Glucose and β-Ketone Control Solutions are for in vitro diagnostic use ONLY (for testing outside the body).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101633 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101633: Nova Max Plus Glocose and B-Ketone Control Solution-Mid, High.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101633
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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