Hemoglobin A2 Quantitation
The Hemoglobin A2 Quantitation test is a hematology diagnostic device used to measure the proportion of hemoglobin A2 in blood, an important marker for the diagnosis of beta-thalassemia trait, in which HbA2 is characteristically elevated above normal reference ranges. This device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification prior to marketing. It carries product code JPD and is regulated under 21 CFR 864.7400, within the Hematology medical specialty. This device is eligible for third-party 510(k) review.
Basic Information
- Product Code
- JPD
- Device Class
- FDA class 2
- Regulation Number
- 864.7400
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K020489 | G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE | May 14, 2002 | Substantially Equivalent | Tosoh Medics, Inc. |
| K991127 | VARIANT II B-THALASSEMIA | Jun 10, 1999 | Substantially Equivalent | Bio-Rad |
| K924122 | VARIANT BETA-THALASSEMIA SHORT PROGRAM | Mar 11, 1993 | Substantially Equivalent | Bio-Rad |
| K924496 | GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT | Nov 16, 1992 | Substantially Equivalent | Drew Scientific , Ltd. |
| K923318 | COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL | Aug 25, 1992 | Substantially Equivalent | Helena Laboratories |
| K923317 | COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL | Aug 25, 1992 | Substantially Equivalent | Helena Laboratories |
| K913384 | COLUMNMATE(TM) BETA-THAL CAT. NO. 4515 | Dec 17, 1991 | Substantially Equivalent | Helena Laboratories |
| K896168 | HEMOGLOBIN A2 MICRO COLUMN TEST | Jan 18, 1990 | Substantially Equivalent | Bio-Rad |
| K875102 | DETER. OF HEMOGLOBIN A2 USING THE DIAMAT | Feb 24, 1988 | Substantially Equivalent | Bio-Rad |
| K823870 | BETA THALQUIK COLUMN #5341 | Feb 01, 1983 | Substantially Equivalent | Helena Laboratories |
| K812077 | HELENA SICKLE-THAL QUIK COLUMN METHOD | Aug 18, 1981 | Substantially Equivalent | Helena Laboratories |
| K803108 | HELENA HBA2 QUIK COLUMN METHOD | Jan 09, 1981 | Substantially Equivalent | Helena Laboratories |
| K801410 | HEMOHLOBIN A2 CONTROL-LYOPHILIZED | Jul 21, 1980 | Substantially Equivalent | Isolab, Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.