ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay
FDA 510(k) K200256 · Siemens Healthcare Diagnostics, Inc.
510(k) numberK200256
Submission
- Device name
- ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay
- Applicant
- Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY, US - Received
- February 3, 2020
- Decision date
- July 2, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PDJ – Hemoglobin A1c Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1373
- Specialty
- Clinical Chemistry
Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.
Other 510(k)s with product code PDJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252749 | Medconn 8K Glycated Hemoglobin Test SystemPDJ · Traditional | Shanghai Medconn Medical Technology Co., Ltd. | 01/06/2026SE |
| K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01PDJ · Traditional | Tosoh Bioscience, Inc. | 10/03/2025SE |
| K242911 | Medconn Glycated Hemoglobin Test systemPDJ · Traditional | Shanghai Medconn Medical Technology Co., Ltd. | 06/20/2025SE |
| K220999 | Hipro Glycosylated Hemoglobin (HbA1c) Test SystemPDJ · Traditional | Shijiazhuang Hipro Biotechnology Co., Ltd. | 09/12/2024SE |
| K200904 | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8PDJ · Traditional | Tosoh Bioscience, Inc. | 08/05/2021SE |
| K193053 | Tina-quant Hemoglobin A1cDx Gen.3PDJ · Traditional | Roche Diagnostics Operations (Rdo) | 03/26/2020SE |
| K182651 | HbA1c AdvancedPDJ · Traditional | Beckman Coulter Ireland, Inc. | 01/16/2019SE |
| K182988 | Afinion HbA1c Dx on Afinion 2PDJ · Special | Alere Technologies AS | 11/29/2018SE |
| K173909 | Dimension Hemoglobin A1c AssayPDJ · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/13/2018SE |
| K173206 | SEKURE HbA1c AssayPDJ · Traditional | Sekisui Diagnostics P.E.I., Inc. | 07/12/2018SE |
More from Sekisui Diagnostics P.E.I., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253528 | Atellica IM CA 19-9 IINIG · Traditional | 08/10/2026SE |
| K261364 | Atellica CH Acetaminophen 2 (ACTM)LDP · Traditional | 07/24/2026SE |
| K251998 | Atellica CH Diazo Total Bilirubin (D_TBil)CIG · Traditional | 02/27/2026SE |
| K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII)JLW · Traditional | 02/06/2026SE |
| K251630 | Atellica IM Total PSA II (tPSAII)LTJ · Traditional | 01/05/2026SE |
| K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII)JNL · Traditional | 12/04/2025SE |
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase IIJZO · Traditional | 10/17/2025SE |
| K242981 | Atellica IM Thyroglobulin (Tg)MSW · Traditional | 06/20/2025SE |
| K243570 | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI…JLW · Traditional | 04/25/2025SE |
| K242685 | Atellica® CH Creatinine_3 (Crea3)CGX · Traditional | 12/04/2024SE |
Questions and answers
When was ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay cleared by the FDA?
ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay (K200256) received a 510(k) decision of Substantially Equivalent on July 2, 2021, 515 days after the submission was received.
What is the product code of K200256?
The FDA product code is PDJ – Hemoglobin A1c Test System, a Class II (moderate risk) device regulated under 21 CFR 862.1373.