Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
FDA 510(k) K222439 · Siemens Healthcare Diagnostics, Inc.
510(k) numberK222439
Submission
- Device name
- Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY, US - Received
- August 12, 2022
- Decision date
- August 8, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LEH – Radioimmunoassay, Vancomycin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3950
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LEH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K160202 | Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)LEH · Traditional | Siemens Healthcare Diagnostics, Inc. | 04/27/2016SE |
| K152245 | ONLINE TDM Vancomycin Gen.3LEH · Traditional | Roche Diagnostics Operations (Rdo) | 01/08/2016SE |
| K123947 | Architect IvancomycinLEH · Traditional | Biokit, S.A. | 08/29/2013SE |
| K072036 | Architect Ivancomycin Reagents and Architect Ivancomycin Calibrators, Models: 1P30-25…LEH · Traditional | Biokit, S.A. | 03/19/2008SE |
| K063045 | Immulite 2000, Immulite 2500 VancomycinLEH · Traditional | Diagnostic Products Corp. | 12/05/2006SE |
| K060586 | Enzyme Immunoassay, VancomycinLEH · Traditional | Roche Diagnostics Corp. | 05/11/2006SE |
| K050419 | QMS VancomycinLEH · Traditional | Seradyn, Inc. | 04/01/2005SE |
| K043386 | Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM Performance Verifiers…LEH · Traditional | Ortho-Clinical Diagnostics, Inc. | 02/07/2005SE |
| K032811 | Cedia Vancomycin AssayLEH · Traditional | Microgenics Corp. | 11/24/2003SE |
| K020692 | Emit 2000 Vancomycin AssayLEH · Traditional | Dade Behring, Inc. | 05/10/2002SE |
More from Dade Behring, 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 Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) cleared by the FDA?
Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) (K222439) received a 510(k) decision of Substantially Equivalent on August 8, 2023, 361 days after the submission was received.
What is the product code of K222439?
The FDA product code is LEH – Radioimmunoassay, Vancomycin, a Class II (moderate risk) device regulated under 21 CFR 862.3950.