# K973791: Abc Calibration Verifiers

- Pathway: 510(k) (Traditional)
- Applicant: Sc Calibrators & Controls, LLC
- Decided: Oct 14, 1997 after 8 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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) DOCUMENT TDM | Linearity Test Set: named in the summary without a submission number
- (no number) LiniCAL Protein Calibration Verifiers: named in the summary without a submission number

## Indications for use
ABC Calibration Verifiers should be used any time it is necessary to confirm the proper calibration and linear operating range of TDM methods and instruments. The Clinical Laboratory Improvement Act and its regulations (CLIA) require verification of linearity and calibration twice a year for modified moderately complex methods, highly complex methods and in-house methods. Verification should be performed more often if any of the following occurs: introduction of procedures for which control values change with a new reagent lot, major preventative maintenance or replacement of critical parts on the instrument, control values exhibit an unusual trend or shift or are outside the acceptable limits of the laboratory, and if the laboratory’s schedule of verification is more frequent.

Source page: https://510kreport.com/device/K973791
Methodology: https://510kreport.com/methodology