510(k) · Cleared
ClearedHitachi S Test Reagent Cartridge Total Protein (TP) and Albumin (Alb)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Chemical Diagnostics, Inc. · JGQ Turbidimetric, Total Protein
Cleared on Jun 7, 2013 as substantially equivalent to K100853 (Roche Diagnostics Corp., 2010) after a 53-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Jun 7, 2013
- Review
- 53 days
- Class
- Class II
- Product code
- JGQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K953239 (1995). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK953239 Boehringer Mannheim/Hitachi 917 AnalyzerBoehringer Mannheim Corp. · 1995 · Recalled
- 2 generations backK060373 Cobas 6000 Series SystemRoche Diagnostics · 2006 · Recalled
- 1 generation backK100853 Cobas 8000 Modular Series AnalyzerRoche Diagnostics Corp. · 2010 · Recalled
- This deviceK131051 Hitachi S Test Reagent Cartridge Total Protein (TP) and Albumin (Alb)Hitachi Chemical Diagnostics, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953239 | Boehringer Mannheim/Hitachi 917 Analyzer | Boehringer Mannheim Corp. | 1995 | 18 |
| −2 | K060373 | Cobas 6000 Series System | Roche Diagnostics | 2006 | 10 |
| −1 | K100853 | Cobas 8000 Modular Series Analyzer | Roche Diagnostics Corp. | 2010 | 11 |
| 0 (this device) | K131051 | Hitachi S Test Reagent Cartridge Total Protein (TP) and Albumin (Alb) | Hitachi Chemical Diagnostics, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 JGQ? 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 |
|---|---|---|---|
| * | K100853 | Cobas 8000 Modular Series AnalyzerSummary page 1…21 CFR § 862.1035 Albumin (ALB) 807.92 (a)(3): Identification of the legally marketed predicate devices Cobas ¢ systems TP2 (Roche Diagnostics, Inc., Indianapolis, IN)- K100853 Cobas ¢ systems ALB2 (Roche Diagnostics, Inc., Indianapolis, IN)- K100853 807.92 (a)(4): Device Description The Hitachi Clinica… | 2010 |
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?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 4 of the 4 ancestors have a recall of any class.
- 8 other devices also cite its predicate K100853.
How does its category compare?
All JGQ devicesJGQ Turbidimetric, Total Protein: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · JGQ
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · JGQ
Too few JGQ 510(k)s in any year since 2007 to give a median.
Recalls per year · JGQ
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JGQ
4in 2025
MAUDE reports naming product code JGQ, 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 | 2 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 10 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The S TEST Reagent Cartridge Total Protein (TP) is intended for the quantitative determination of TP in serum, lithium heparinized plasma, K3 EDTA plasma and sodium citrate plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge TP is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. Total protein measurements are used in the diagnosis and treatment of a variety of diseases…
Read the full statement (161 words)
The S TEST Reagent Cartridge Total Protein (TP) is intended for the quantitative determination of TP in serum, lithium heparinized plasma, K3 EDTA plasma and sodium citrate plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge TP is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Total protein measurements are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.
The S TEST Reagent Cartridge Albumin (ALB) is intended for the quantitative determination of ALB in serum, lithium heparinized plasma, K3 EDTA plasma and sodium citrate plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge ALB is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
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/K131051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131051: Hitachi S Test Reagent Cartridge Total Protein (TP) and Albumin (Alb).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131051
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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