510(k) Report

510(k) · Cleared

Cleared

Calibrating Material,Cal-Pak, Cal & Slope Standards

K020596510(k) TraditionalCleared Mar 23, 200229-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 Mar 23, 2002 after a 29-day review. The FDA summary names its predicate without a number.

Decided
Mar 23, 2002
Review
29 days
Class
Class II
Product code
JIT
Recalls
None
Predicates
0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K020596Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*—614 Cal-Pak Na+/K+
Named without a submission number
—
*—634 Cal-Pak Ca++/pH
Named without a submission number
—
*—644 Cal-Pak Na+/K+/Cl-
Named without a submission number
—
*—654 Cal-Pak Na+/K+/Li+
Named without a submission number
—

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.

How does its category compare?

All JIT devices

JIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JIT

7in 2017

2007: 52008: 62009: 22010: 62011: 72012: 22013: 52014: 102015: 42016: 42017: 7
2007high 10 (2014) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JIT

28in 2017

2007: 78 days median2008: 46 days median2010: 65 days median2011: 48 days median2013: 140 days median2014: 33 days median2015: 30 days median2016: 33 days median2017: 28 days median
2007high 140 (2013) · low 28 (2017)2026

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

Recalls per year · JIT

1in 2023

2007: 12009: 22011: 32012: 32014: 22015: 12018: 52020: 22023: 12026 (partial year): 1
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

2010: 32011: 22012: 102013: 432014: 92015: 62016: 32017: 72018: 82019: 2152020: 122021: 32022: 42023: 62024: 172025: 7
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200757810
200864600
20092—20
201066503
201174832
20122—310
20135140043
2014103329
201543016
201643303
201772807
20180—58
20190—0215
20200—212
20210—03
20220—04
20230—16
20240—017
20250—07
20260—1—

What is it indicated for?

The products encompassed by this request are intended for in-vitro diagnostics use and for use in calibrating the electrodes and flushing the sample flow path of the equivalent Corning 6X4 Series Electrolyte Analyzers. Corning (name changes incl.: Corning Glass, Ciba-Corning, Chiron, and currently Bayer) is the Original Equipment Manufacturer (OEM) of the analyzers and the predicate reagents.

Mission reagents are intended to serve as direct replacements to like named products manufactured by Corning (under the label of current owner, Bayer).

The products encompassed are to be handled using normal laboratory precautions.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Diamond Diagnostics, Inc.

26 FDA decisions under this applicant name. See the company

  • K200544SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics, Inc. · 2020
  • K133751Diamond Diagnostics Ise Serum Standards, Diamond Diagnostics Ise Urine StandardsDiamond Diagnostics, Inc. · 2014
  • K124009Mission Clinicheck Assayed Chemistry Controls, Level 1, Mission Clinicheck Assayed Chemistry Controls Level…Diamond Diagnostics, Inc. · 2013
  • K121027Diamond Calibrator Low, Diamond Calibrator HighDiamond Diagnostics, Inc. · 2012
  • K121040Smartlyte Electrolyte AnalyzerDiamond Diagnostics, Inc. · 2012

Recent decisions in JIT

The JIT category page

  • K171168VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical Diagnostics · 2017
  • K170938CalSet IGF-1Roche Diagnostics · 2017
  • K170160Abbott ARCHITECT Free T3Abbott Laboratories · 2017
  • K163546Lumipulse G Progesterone-N CalibratorsFujirebio Diagnostics,Inc. · 2017
  • K163534Lumipulse G FSH-N CalibratorsFujirebio Diagnostics,Inc. · 2017

https://510kreport.com/device/K020596 · printed Nov 3, 2026

Cite this page

510(k) Report. “K020596: Calibrating Material,Cal-Pak, Cal & Slope Standards.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K020596

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026