# K963286: Immage Immunochemistry System Haptoglobin (HPT) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Oct 7, 1996 after 47 days
- Product code: DAD (Haptoglobin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Beckman immunochemistry Systems HPT Haptoglobin Reagent: named in the summary without a submission number

## Indications for use
The IMMAGE Immunochemistry System Haptoglobin (HPT) reagent, in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of human haptoglobin concentrations in human serum samples by rate nephelometry. This assay is designed for use with Beckman's IMMAGE Immunochemistry System.

Source page: https://510kreport.com/device/K963286
Methodology: https://510kreport.com/methodology