510(k) Report

510(k) · Cleared

Cleared

Calibrating Material, Calibrating Standards

K033060510(k) TraditionalCleared Mar 4, 2004157-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 4, 2004 as substantially equivalent to K943570 (Avl Scientific Corp., 1994) and 8 other predicates after a 157-day review. Its family tree reaches back 2 generations to 1993.

Decided
Mar 4, 2004
Review
157 days
Class
Class II
Product code
JIT
Recalls
None
Predicates
9

Its longest line of descent runs back 2 generations to K933373 (1993). 10 ancestors in all, the oldest K811194 (1981). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 1 other ancestor1994: 2 other ancestors1990: 1 other ancestor1989: 1 other ancestor1986: 1 other ancestor1985: 1 other ancestor1981: 1 other ancestorK933373 · Ciba Corning 300 Series System · Ciba Corning Diagnostics Corp. · 1993K962021 · Ciba Corning 348 System · Ciba Corning Diagnostics Corp. · 1996198019851990199520002005
Other ancestors, by generation 1 generation back: 8 other ancestors K962021 · Ciba Corning 348 System · Ciba Corning Diagnostics Corp. · 1996K933373 · Ciba Corning 300 Series System · Ciba Corning Diagnostics Corp. · 19930
  1. Root · 2 generations backK933373 Ciba Corning 300 Series SystemCiba Corning Diagnostics Corp. · 1993
  2. 1 generation backK962021 Ciba Corning 348 SystemCiba Corning Diagnostics Corp. · 1996
  3. This deviceK033060 Calibrating Material, Calibrating StandardsDiamond Diagnostics, Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K933373Ciba Corning 300 Series SystemCiba Corning Diagnostics Corp.1993—
−1K962021Ciba Corning 348 SystemCiba Corning Diagnostics Corp.1996—
0 (this device)K033060Calibrating Material, Calibrating StandardsDiamond Diagnostics, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198510
198610
198910
199010
199420
199510
FIG. 1 — Lineage of K033060, 1993–2004Source: FDA 510(k) summaries, read by 510(k) Report · 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
Get a 510(k) Report

What was it cleared against? (14)

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
*K943570Avl Compact 1 PH/Blood Gas Analyzer
Summary page 1
…Cleared Date 1 AV-BP1579D BG Calibrator BP1579 BG Calibrator K943570 08-24-1 994 2 CD-1056700 Hct Slope 105670 Hct Slope K962021…
Avl Scientific Corp.1994—
*K962021Ciba Corning 348 System
Summary page 1
…BP1579 BG Calibrator K943570 08-24-1 994 2 CD-1056700 Hct Slope 105670 Hct Slope K962021 06-24-1996 634 Ca/pH Slope 634 Slope Standard 3 CD-47181…
Ciba Corning Diagnostics Corp.1996—
*K844188Corning Calcium PH Analyzer 634
Summary page 1
…634 Ca/pH Slope 634 Slope Standard 3 CD-471818D Standard 471818 2 .5 0 /6 8. 4 pH K844188 11-23-1988 654 Lithium Slope 654 Lithium Slope 4 CD-473606…
Corning Medical & Scientific1985—
*K884769Model 654 a Sodium, Potassium & Lithium Ise Analy
Summary page 1
…654 Lithium Slope 654 Lithium Slope 4 CD-473606D Solution 2.50 mmol/L 473606 Solution 2.50 mmol/L. K884769 01-17-1989 5 CD-473692D pH- Blood Gas Slope 473692 pH Blood Gas Slope_ K904188 0…
Ciba Corning Diagnostics Corp.1989—
*K904188Ciba Corning Model 238 PH/ Blood Gas Analyzer
Summary page 1
…473606 Solution 2.50 mmol/L. K884769 01-17-1989 5 CD-473692D pH- Blood Gas Slope 473692 pH Blood Gas Slope_ K904188 09-27-1990 Calibrating Solution 1, Calibrating Solution 1, 6 RD-…
Ciba Corning Diagnostics Corp.1990—
*K954612Abl System 625, 615, 605
Summary page 1
…Calibrating Solution 1, Calibrating Solution 1, 6 RD-944015D Bt #9 944015 Btl#9 K954612 11-09-1995 Calibrating Solution 1, Calibrating Solution 1, 7 RD…
Radiometer America, Inc.19951
*K942676Synchron CX3 Delta
Summary page 1
…BK-465908D Calibrator 1 465908 Calibrator 1 10 BK-465909D Calibrator 2 465909 Calibrator 2 K942676 11-02-1994 11 BK-465910OD Calibrator 3 465910 Calibrator 3 12 BK-443360D…
Beckman-Diagnostic Systems Group1994—
*K864236Synchron CX3
Summary page 1
…1 BK-465910OD Calibrator 3 465910 Calibrator 3 12 BK-443360D Calibration Standard 1 443360 Calibration Standard 1 K864236 12-31-1 986 13 BK-443365D Calibration Standard 2 443365 Calibration Standard 2 14 BM…
Beckman Instruments, Inc.1986—
*K811194Hitachi 705 Automatic Blood Chemistry
Summary page 1
…443365D Calibration Standard 2 443365 Calibration Standard 2 14 BM-620427D ISE Standard High 620427 ISE Standard High K811194 05-27-1981 15 BM-620428D ISE Standard Low 624028 ISE Standard Low ____________…
Boehringer Mannheim Corp.1981—
*—634 Slope Standard
Named without a submission number
—
*—654 Lithium Slope
Named without a submission number
—
*—944030 Calibrating Solution 1, Btl#3
Named without a submission number
—
*—944031 Calibrating Solution 2, Btl#4
Named without a submission number
—
*—624028 ISE Standard Low
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.

What does this lineage say?

  • The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 7.7 years on median.
  • 1 of the 10 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.

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 are intended for use in calibrating equivalent OEM Analyzers. Provide a second calibration point for AVL Compact 1 pH/Blood Gas Analyzer. Provide a second calibration point for the Hct sensor on the 348 Analyzer. To provide a second calibration point for the Ca & pH electrodes on the 634 Ca/pH Analyzer. To provide a second calibration point for the Lithium electrode on…

Read the full statement (349 words)

The products encompassed by this request are intended for in-vitro diagnostics use and are intended for use in calibrating equivalent OEM Analyzers.

Provide a second calibration point for AVL Compact 1 pH/Blood Gas Analyzer.

Provide a second calibration point for the Hct sensor on the 348 Analyzer.

To provide a second calibration point for the Ca & pH electrodes on the 634 Ca/pH Analyzer.

To provide a second calibration point for the Lithium electrode on the 654 Na/K/Li Analyzer.

To provide a second calibration point for pH, pCO2, and PO2 on 238 pH/Blood Gas Analyzer.

To provide a calibration point for the Na+, K+, Ca+, Cl-, pH and glucose, lactate electrodes on Radiometer 605, 615, 625, EML 100 & 105 Analyzers.

To provide a calibration point for the Na+, K+, Ca+, Cl-, pH and glucose, lactate electrodes on Radiometer 605, 615, 625, EML 100 & 105 Analyzers.

To provide a second calibration point for the Na+, K+, Ca+, Cl-, and pH electrodes on Radiometer 555 Analyzer.

Used in conjunction with Calibrator 2 and 3 to calibrate Na, K, Cl, Ca, TCO2, Glucose, BUN, & Creatinine on Beckman Synchron CX Delta, CX®CE, and CX9 ALX Systems.

Used in conjunction with Calibrator 1 and 3 to calibrate Na, K, Cl, Ca, TCO2, Glucose, BUN, & Creatinine on Beckman Synchron CX Delta, CX®CE, and CX9 ALX Systems.

Used in conjunction with Calibrator 1 and 2 to calibrate Na, K, Cl, Ca, TCO2, Glucose, BUN, & Creatinine on Beckman Synchron CX Delta, CX®CE, and CX9 ALX Systems.

Used in conjunction with Calibration Standard 2 to calibrate Na, K, Cl, Ca, TCO2, Glucose, BUN, & Creatinine on Beckman Synchron CX3 and CX5 Systems.

Used in conjunction with Calibration Standard 1 to calibrate Na, K, Cl, Ca, TCO2, Glucose, BUN, & Creatinine on Beckman Synchron CX3 and CX5 Systems.

To provide a calibration point for Na+, K+ and Cl- electrodes on the ISE module of Hitachi 7xx, 911, 912 and 917 Analyzers.

To provide a calibration point for Na+, K+ and Cl- electrodes on the ISE module of Hitachi 7xx, 911, 912 and 917 Analyzers.

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

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https://510kreport.com/device/K033060 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033060: Calibrating Material, Calibrating Standards.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033060

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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