Product code QLX— Microbiology

“A quantitative viral nucleic acid test for transplant patient management is identified as a device intended for prescription use in the detection of viral pathogens by measurement of viral deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) using specified specimen processing, amplification, and detection instrumentation. The test is intended for use as an aid in the management of transplant patients with active viral infection or at risk for developing viral infections. The test results are intended to be interpreted by qualified healthcare professionals in conjunction with other relevant clinical and laboratory findings.”

FDA has cleared 4 devices under product code QLX between 2020 and 2025, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20251 clearance
• 20221 clearance
• 20211 clearance
• 20201 clearance

• Roche Molecular Systems, Inc.2 clearances
• Abbott Molecular, Inc.2 clearances

• K243489 — Alinity m EBV (09N43-095)Abbott Molecular, Inc.·2025-07-28
• K212778 — Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)Abbott Molecular, Inc.·2022-07-15
• K203220 — cobas BKVRoche Molecular Systems, Inc.·2021-01-29
• DEN200015 — cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control KitRoche Molecular Systems, Inc.·2020-07-30