# K033060: Calibrating Material, Calibrating Standards

- Pathway: 510(k) (Traditional)
- Applicant: Diamond Diagnostics, Inc.
- Decided: Mar 4, 2004 after 157 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K933373 (1993). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943570: Avl Compact 1 PH/Blood Gas Analyzer, Avl Scientific Corp. (1994) Summary page 1.
- K962021: Ciba Corning 348 System, Ciba Corning Diagnostics Corp. (1996) Summary page 1.
- K844188: Corning Calcium PH Analyzer 634, Corning Medical & Scientific (1985) Summary page 1.
- K884769: Model 654 a Sodium, Potassium & Lithium Ise Analy, Ciba Corning Diagnostics Corp. (1989) Summary page 1.
- K904188: Ciba Corning Model 238 PH/ Blood Gas Analyzer, Ciba Corning Diagnostics Corp. (1990) Summary page 1.
- K954612: Abl System 625, 615, 605, Radiometer America, Inc. (1995) Summary page 1.
- K942676: Synchron CX3 Delta, Beckman-Diagnostic Systems Group (1994) Summary page 1.
- K864236: Synchron CX3, Beckman Instruments, Inc. (1986) Summary page 1.
- K811194: Hitachi 705 Automatic Blood Chemistry, Boehringer Mannheim Corp. (1981) Summary page 1.
- (no number) 634 Slope Standard: named in the summary without a submission number
- (no number) 654 Lithium Slope: named in the summary without a submission number
- (no number) 944030 Calibrating Solution 1, Btl#3: named in the summary without a submission number
- (no number) 944031 Calibrating Solution 2, Btl#4: named in the summary without a submission number
- (no number) 624028 ISE Standard Low: named in the summary without a submission number

## Indications for use
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.

Source page: https://510kreport.com/device/K033060
Methodology: https://510kreport.com/methodology