# K971333: Synchron Systems Alkaline Phosphatase Reagent, Cholinesterase Reagent, Gamma-Glutamyl Transferase Reagent, Lactate Dehyd

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: May 23, 1997 after 43 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- 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: 1 generation back to K881498 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881498: Synchron CX (TM)4 Clinical Analyzer, Beckman Instruments, Inc. (1988) Summary page 2.

## Cited in the summary but kept off the family tree
- K893583: Beckman Cholinesterase Reagent Kit, Beckman (1989). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K851064: Cordis HI-Flex Pervenous Active Fixation Unipolar, Cordis Corp. (1986). Our OCR of the scanned summary read K851064, FDA’s number for Cordis HI-Flex Pervenous Active Fixation Unipolar (Cordis Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “SYNCHRON Enzyme Validator Set”. Kept off the family tree.

## Indications for use
The SYNCHRON Systems Alkaline Phosphatase (ALP) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of alkaline phosphatase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) or the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh). The SYNCHRON Systems Cholinesterase (CHE) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of pseudo-cholinesterase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh). The SYNCHRON Systems γ-Glutamyl Transferase (GGT) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of γ-glutamyl transferase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh). The SYNCHRON Systems Alkaline Phosphatase (ALP) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of alkaline phosphatase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) or the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh). The SYNCHRON Systems Cholinesterase (CHE) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of pseudo-cholinesterase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).

Source page: https://510kreport.com/device/K971333
Methodology: https://510kreport.com/methodology