# K013850: Standard a, Standard B, Standard C, Cal, Slope

- Pathway: 510(k) (Traditional)
- Applicant: Diamond Diagnostics, Inc.
- Decided: Dec 21, 2001 after 31 days
- Product code: JIT (Calibrator, Secondary)
- 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
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) AVL BP0936 Standard A: named in the summary without a submission number
- (no number) AVL BP0937 Standard B: named in the summary without a submission number
- (no number) AVL BP0938 Standard C: named in the summary without a submission number
- (no number) AVL BP0442 Standard B: named in the summary without a submission number
- (no number) AVL BP1232 Standard A: named in the summary without a submission number
- (no number) AVL BP1218 Standard B: named in the summary without a submission number
- (no number) AVL BP1203 Standard A: named in the summary without a submission number
- (no number) AVL BP1201 Standard B: named in the summary without a submission number

## Indications for use
The products encompassed by this request are intended for in-vitro diagnostics use and are intended for use in calibrating the electrodes and flushing the sample flow path of the equivalent AVL 98X series Analyzers. AVL Scientific Corp is the Original Equipment Manufacturer (OEM) of the analyzers and the predicate reagents. Standard A AV-BP0936D | 982, 983, 985, 988-3 (Cl, Li) Standard B AV-BP0937D | 985, 988-3 (Cl, Li) Standard B AV-BP0442D | 982, 983 Standard C AV-BP0938D | 985, 988-3 (Li) Standard A AV-BP1232D | 984, 987, 988-3 (Ca), 988-4 Standard B AV-BP1218D | 984, 987, 988-3 (Ca), 988-4 Standard A AV-BP1203D | 986 Standard B AV-BP1201D | 986 Mission reagents are intended to serve as direct replacements to like named products manufactured by AVL. The products encompassed are to be handled using normal laboratory precautions.

Source page: https://510kreport.com/device/K013850
Methodology: https://510kreport.com/methodology