# K934070: Tina-Quant Hemoglobin A1C

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Oct 11, 1994 after 417 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 6 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K052101: C.F.a.S. (Calibrator for Automated Systems) HBA1C (2005), 6 descendants of its own
- K130255: Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C Controls (2014), 4 descendants of its own
- K052464: Tina-Quant Hemoglobin A1C Gen.2 Test (2005), 3 descendants of its own
- K072714: Tina-Quant Hemoglobin A1C Gen.2 Test System (2008), 2 descendants of its own
- K171771: ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay (2017), 1 descendant of its own

Source page: https://510kreport.com/device/K934070
Methodology: https://510kreport.com/methodology