K110251 · Beckman Coulter, Inc. · JIX · May 25, 2011 · Clinical Chemistry
Device Facts
Record ID
K110251
Device Name
SYNCHRON MULTI CALIBRATOR
Applicant
Beckman Coulter, Inc.
Product Code
JIX · Clinical Chemistry
Decision Date
May 25, 2011
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 862.1150
Device Class
Class 2
Indications for Use
The SYNCHRON MULTI CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate, Magnesium, Total Protein, Triglycerides, and Uric Acid. Prescription use.
Device Story
SYNCHRON MULTI CALIBRATOR is a liquid, ready-to-use, multi-analyte in vitro diagnostic calibrator; matrix consists of human serum stabilized with ethylene glycol. Device used on Beckman Coulter SYNCHRON CX, LX, and UniCel DxC family of analyzers. Calibrator provides known concentration values for specific analytes (Albumin, BUN, Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate, Magnesium, Total Protein, Triglycerides, Uric Acid) to calibrate clinical chemistry assays. Healthcare providers use the resulting assay measurements to aid in clinical decision-making. Product is handled by laboratory technicians; requires storage at -15 to -20°C.
Clinical Evidence
No clinical data. Bench testing only. Value assignment for Lactate and Magnesium was validated through multiple runs across multiple SYNCHRON analyzer platforms (CX5 CE, CX9 Pro, LX20 Pro, DxC800) using multiple reagent lots. Traceability established via NIST SRM 929 for Magnesium and manufacturer working calibrators for Lactate.
Technological Characteristics
Liquid, ready-to-use, human serum matrix stabilized with ethylene glycol. Multi-analyte mixture. Traceable to NIST SRM 927a, 915, 911b, 917a, 929, 3139a, 912a, 913b. Storage: -15°C to -20°C. Open vial stability: 20 days at 2°C to 8°C. Packaging: 6 x 20 mL bottles.
Indications for Use
Indicated for use as a calibrator for clinical chemistry assays on Beckman Coulter SYNCHRON systems. No specific patient population or disease state is defined as this is a laboratory calibration product.
Regulatory Classification
Identification
A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k110251
B. Purpose for Submission:
Add Lactate (lactic acid) and Magnesium to the previously cleared Synchron Systems Multi Calibrator for albumin, BUN, calcium, cholesterol, creatinine, glucose, inorganic phosphorus, total protein, triglycerides and uric acid.
C. Measurand:
Calibrator for Lactate (Lac) and Magnesium (Mg)
D. Type of Test:
Not applicable
E. Applicant:
Beckman Coulter, Inc.
F. Proprietary and Established Names:
SYNCHRON Multi Calibrator
G. Regulatory Information:
1. Regulation section:
21 CFR 862.1150, Calibrator
2. Classification:
Class II
3. Product code:
JIX, Calibrator, Multi-Analyte Mixture
4. Panel:
75, Clinical Chemistry
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H. Intended Use:
1. Intended use(s):
See Indications for use below.
2. Indication(s) for use:
The SYNCHRON MULTI CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate, Magnesium, Total Protein, Triglycerides, and Uric Acid.
3. Special conditions for use statement(s):
Prescription use.
4. Special instrument requirements:
Beckman Coulter SYNCHRON CX, LX and UniCel DxC family of analyzers and SYNCHRON reagents.
I. Device Description:
The SYNCHRON MULTI CALIBRATOR is a liquid, ready-to-use multi-analyte, in vitro diagnostic calibrator. The SYNCHRON Multi Calibrator is prepared in a human serum matrix which is stabilized by the use of ethylene glycol. During manufacture, the multiple constituents are spiked into the matrix at the desired concentration levels.
The analytes in this calibrator are traceable using prEN ISO 17511 to the following:
| Measurand | Traceable to: |
| --- | --- |
| Albumin (ALB) | NIST 927a |
| Calcium (CA) | NIST SRM 915 |
| Cholesterol (CHOL) | NIST 911b |
| Glucose (GLU) | NIST SRM 917a |
| Lactate | Manufacturer’s working calibrator |
| Magnesium (MG) | NIST SRM 929 |
| Inorganic Phosphorus (PHOS) / (PHS) / (PO4) | NIST SRM 3139a |
| Total Protein (TP) | NIST SRM 927a |
| Triglyceride (TG) / (TG-B) | Manufacturer’s working calibrator |
| Urea, Blood Urea Nitrogen (BUN) | NIST SRM 912a |
| Uric Acid | NIST SRM 913b |
Creatinine was removed from the SYNCHRON MULTI CALIBRATOR and is now separate (k095240). The traceability was changed from NIST traceable to Isotope
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Dilution Mass Spectrometry, (k071277).
All serum or plasma donor units used in the preparation of this material were tested by FDA approved methods and found to be negative for HIV, and HCV antibodies, as well as non-reactivity for HBs Ag. Because no test method can offer complete assurance that HIV, hepatitis B virus, and hepatitis C virus or other infections agents are absent, this material should be handled as though capable of transmitting infectious diseases. This product may also contain other human source material for which there is no approved test.
## J. Substantial Equivalence Information:
1. Predicate device name(s):
SYNCHRON MULTI CALIBRATOR
2. Predicate K number(s):
k883181
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate k883181 |
| Intended Use | Same | Calibration of Synchron Systems |
| Matrix base | Same | Human serum and stabilized with ethylene glycol |
| Format | Same | Liquid, ready-to-use |
| Levels | Same | 1 |
| Open vial stability | Same | 20 days at 2-8°C |
| Real time stability | Same | 24 months |
| Storage | Same | -15 to -20°C |
| Packaging | Same | 6x20 mL bottles |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Calibrator analytes | Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate, Magnesium, Total Protein, Triglycerides, and Uric Acid. | Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Creatinine, Glucose, Inorganic Phosphorus, Total Protein, Triglycerides, and Uric Acid. |
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K. Standard/Guidance Document Referenced (if applicable):
None were referenced.
L. Test Principle:
Not applicable
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Not applicable
b. Linearity/assay reportable range:
Not applicable
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Traceability: Lactate is gravimetrically prepared and is traceable to an older lot of calibrator. Magnesium is traceable to NIST 929.
Value Assignment: Value assignment of the lactate calibrator is established by comparing lactate recovery to the previous lot of calibrator and by evaluating lactate recovery against a commercially available set of standards. Bottle value assignment occurs by performing multiple runs over multiple days with the new lot using multiple SYNCHRON Systems—CX5 CE, CX9 Pro, LX20 Pro, DxC800, and two lots of SYNCHRON reagents. Magnesium value assignment is accomplished using an anchor pool, traceable to the NIST 929 reference method. Bottle value assignment occurs by performing multiple runs over multiple days on multiple SYNCHRON Systems using two lots of SYNCHRON reagents.
Stability: Real time stability study data supports the manufacturer labeling that the Beckman Coulter SYNCHRON Multi-Calibrator is stable for 24 months when stored unopened at -15 to -20 °C. Real time stability study data supports an open vial stability claim of 20 days at 2-8°C. Calibrators are not stored on board the instruments.
d. Detection limit:
Not applicable
e. Analytical specificity:
4
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Not applicable
f. Assay cut-off:
Not applicable
2. Comparison studies:
a. Method comparison with predicate device:
Not applicable
b. Matrix comparison:
Not applicable
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable
4. Clinical cut-off:
Not applicable
5. Expected values/Reference range:
Not applicable
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
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Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
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A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
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Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
