AABB FDA 510(k) Third-Party Review Service FAQs

The FDA designed this program to expedite decisions for lower-risk devices, freeing up agency resources for higher-risk products. Approximately half of the 510(k)s the FDA receives are eligible for this program. As an accredited 3P510k review organization, AABB is permitted to work directly with companies, facilitating FDA review and clearance.

The process allows manufacturers to submit 510(k) device premarket applications directly to AABB, and the sole payment is between the 510(k) submitter and AABB. The Association then reviews the submission and makes recommendations to the FDA. The agency maintains oversight of the review process, granting the final approval. AABB then shares the decision with the applicant.

Learn more about the 510(k) Third-Party Review Program

AABB is accredited to review the premarket submissions for eligible device types regulated as hematology, pathology, microbiology, general hospital and clinical chemistry devices, including:

CLINICAL CHEMISTRY

• Lipoprotein test system
• Blood specimen collection devices
• General purpose laboratory equipment labeled or promoted for a specific medical use

CARDIOVASCULAR

• Blood pressure cuff

HEMATOLOGY

• Automated cell counter
• Automated differential cell counter
• Automated cell-locating device
• Red cell indices device
• Multipurpose system for in vitro coagulation studies
• Automated platelet aggregation system
• Blood volume measuring device
• Occult blood test
• Platelet aggregometer
• Activated whole blood clotting time tests
• Fibrinogen/fibrin degradation products assay
• Fibrinogen determination system
• Abnormal hemoglobin assay
• Carboxyhemoglobin assay
• Fetal hemoglobin assay
• Whole blood hemoglobin assays
• Heparin assay
• Prothrombin time test
• Sickle cell test
• Thrombin time test
• Partial thromboplastin time tests
• Quality control kit for blood banking reagents

MICROBIOLOGY

• Antimicrobial susceptibility test disc
• Culture medium for antimicrobial susceptibility tests
• Transport culture medium
• Microbial growth monitor
• Microbiological specimen collection and transport device
• Cytomegalovirus serological reagents
• Respiratory syncytial virus serological reagents
• Treponema pallidum nontreponemal test reagents
• Treponema pallidum treponemal test reagents

GENERAL HOSPITAL

• Sterilization process indicator
• Clinical electronic thermometer
• Intravascular administration set
• Hypodermic single lumen needle
• Non-powdered patient examination glove
• Sterilization wrap
• Dry-heat sterilizer
• Steam sterilizer

GENERAL & PLASTIC SURGERY

• Surgical apparel

The full list of eligible device types that AABB is eligible to review is available on the FDA website

The U.S. Food and Drug Administration (FDA) issued a final rule establishing a regulatory framework for laboratory-developed tests (LDTs). FDA anticipates that half of LDTs subject to premarket review requirements will be reviewed under its 510(k) Third Party Review Program. AABB is approved by FDA as a third-party review organization and is available to review premarket submissions for eligible device types regulated as hematology, pathology, microbiology, general hospital and clinical chemistry devices.

AABB has additional information and resources available on our website.

Companies who are looking for support in getting a product to the FDA Third-Party Review process, or with questions related to product development and approval may benefit from working with AABB Consulting Services. Our team of expert consultants can provide tailored, specialized consultations and analyses to help optimize your company's growth.

Please note that if we help with preparation of 510k review, we will not review the submission on behalf of FDA.