510(k) · Cleared

Cleared

Diamond Diagnostics Ise Serum Standards, Diamond Diagnostics Ise Urine Standards

K133751510(k) TraditionalCleared Aug 8, 2014242-day reviewClass II21 CFR 862.1150

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Diamond Diagnostics, Inc. · JIT Calibrator, Secondary

Cleared on Aug 8, 2014 as substantially equivalent to K121027 (Diamond Diagnostics, Inc., 2012) after a 242-day review. Its family tree reaches back 2 generations to 1995.

Decided: Aug 8, 2014
Review: 242 days
Class: Class II
Product code: JIT
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K945271 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK945271 Atac 8000 Random Access Chemistry SystemBio-Chem Laboratory Systems, Inc. · 1995 · Recalled
1 generation backK121027 Diamond Calibrator Low, Diamond Calibrator HighDiamond Diagnostics, Inc. · 2012
This deviceK133751 Diamond Diagnostics Ise Serum Standards, Diamond Diagnostics Ise…Diamond Diagnostics, Inc. · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K945271	Atac 8000 Random Access Chemistry System	Bio-Chem Laboratory Systems, Inc.	1995	1
−1	K121027	Diamond Calibrator Low, Diamond Calibrator High	Diamond Diagnostics, Inc.	2012	—
0 (this device)	K133751	Diamond Diagnostics Ise Serum Standards, Diamond Diagnostics Ise Urine Standards	Diamond Diagnostics, Inc.	2014	—

FIG. 1 — Lineage of K133751, 1995–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 JIT? 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

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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	Applicant	Decided	Recalls
*	K121027	Diamond Calibrator Low, Diamond Calibrator High Summary page 5 …Standard High Predicate Device: Diamond Diagnostics ATAC 8000/Envoy 500 ISE Serum Calibrators Predicate 510(k) number(s): k121027 Comparison with predicate: Diamond Diagnostics ISE Serum Standards Similar…	Diamond Diagnostics, Inc.	2012	—

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 19 years and passes through 2 companies; a new generation was cleared every 17.7 years on median.
1 of the 2 ancestors has a recall of any class.

How does its category compare?

All JIT devices

JIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · JIT

7in 2017

2007high 10 (2014) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JIT

28in 2017

2007high 140 (2013) · low 28 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JIT

1in 2023

2007high 5 (2018) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JIT

7in 2025

2007high 215 (2019) · low 0 (2007)2025

MAUDE reports naming product code JIT, 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	5	78	1	0
2008	6	46	0	0
2009	2	—	2	0
2010	6	65	0	3
2011	7	48	3	2
2012	2	—	3	10
2013	5	140	0	43
2014	10	33	2	9
2015	4	30	1	6
2016	4	33	0	3
2017	7	28	0	7
2018	0	—	5	8
2019	0	—	0	215
2020	0	—	2	12
2021	0	—	0	3
2022	0	—	0	4
2023	0	—	1	6
2024	0	—	0	17
2025	0	—	0	7
2026	0	—	1	—

What is it indicated for?

Diamond Diagnostics ISE Serum Standards are intended for in-vitro diagnostics to provide calibration points for the

sodium, potassium, and chloride electrodes on ADVIA Chemistry systems in Human Serum mode.

Diamond Diagnostics ISE Urine Standards are intended for in-vitro diagnostics to provide calibration points for the

sodium, potassium, and chloride electrodes on ADVIA Chemistry systems in Human Urine mode.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K133751 · printed Nov 3, 2026

Cite this page

510(k) Report. “K133751: Diamond Diagnostics Ise Serum Standards, Diamond Diagnostics Ise Urine Standards.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K133751

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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