# K973932: Beckman Calibrator 2 (CAL2)

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Dec 15, 1997 after 61 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 K771603 (1977). 5 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K771603: Immochemistry System, Beckman Instruments, Inc. (1977) Summary page 1.
- K780913: Additional Reagents Kits for Imm. System, Beckman Instruments, Inc. (1978) Summary page 1.
- K791339: Human Ceruloplasmin, Beckman Instruments, Inc. (1979) Summary page 1.
- K791340: Human ALPHA2 Macroglobulin, Beckman Instruments, Inc. (1979) Summary page 1.
- K940353: Beckman Beta-2-Microglobulin (B2M), Beckman Instruments, Inc. (1994) Summary page 1.

## Cited in the summary but kept off the family tree
- K501977: Beckman Calibrator 2 (AT3). Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## Most influential descendants
- K052819: Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers I, II and Iii (2005), 3 descendants of its own
- K061588: Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator Kit 27, Hcy Performance Verifiers (2006), 1 descendant of its own
- K123930: Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance Verifiers I, II and Iii (2013), 0 descendants of its own
- K060940: Vitros Chemistry Products Calibrator Kit 99, Vitros Chemistry Products Aat/HPT Performance Verifier I, II, and Iii (2006), 0 descendants of its own

## Indications for use
CAL 2 (Calibrator 2), when used in conjunction with Beckman alpha₁-antitrypsin (AAT), ceruloplasmin (CER), properdin factor B (PFB), beta-2-microglobulin (B2M), alpha₂-macroglobulin (AMG) and antithrombin III (AT3) reagents, is intended for used on Array®, Array® 360, and IMMAGE™ Systems for the calibration of these reagents.

Source page: https://510kreport.com/device/K973932
Methodology: https://510kreport.com/methodology