# PDJ: Hemoglobin A1c Test System

- Device class: 2; regulation: 21 CFR 862.1373; FDA's rule: 510(k) required
- FDA decisions: 27
- 510(k) review time 2021–2025: median 486 days (middle half 269–515)
- Recalls: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2015: 4
- 2016: 2
- 2017: 3
- 2018: 5
- 2019: 1
- 2020: 1
- 2021: 2
- 2024: 1
- 2025: 2
- 2026: 2

## Most-cited predicates
- DEN130002: Tina-Quant HBA1C Gen. 2 Test System (2013), cited by 7
- K151321: D-100 HbA1c, D-100 HbA1c Calibrator Pack (2015), cited by 4
- K130255: Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C Controls (2014), cited by 3
- K131580: Automated Gylcohemoglobin Analyzer HLC-723G8 (2014), cited by 3
- K142448: VARIANT II TURBO HbA1c Kit - 2.0 (2015), cited by 2
- K200904: Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 (2021), cited by 1
- K121610: Cobas C 501 Tina-Quant HBA1CDX Gen.3 Assay (2013), cited by 1
- K160571: cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay (2016), cited by 1
- K180296: Afinion HbA1c Dx (2018), cited by 1
- K171771: ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay (2017), cited by 1

Source page: https://510kreport.com/product-code/PDJ
Data by year (CSV): https://510kreport.com/product-code/PDJ.csv