JCM · Control, Hemoglobin, Abnormal
Hematology · 21 CFR 864.7415 · Class 2
Overview
| Product Code | JCM |
|---|---|
| Device Name | Control, Hemoglobin, Abnormal |
| Regulation | 21 CFR 864.7415 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to isolate and identify abnormal genetically determined hemoglobin types.
Classification Rationale
Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Special Controls
*Classification.* Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K053031 | EXTENDSURE HBFASC CONTROL | Cantebury Scientific , Ltd. | Dec 7, 2005 | SESE |
| K011389 | HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) | Canterbury Health Laboratories | Jun 21, 2001 | SESE |
| K983704 | MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE | Roche Diagnostic Systems, Inc. | Feb 10, 1999 | SESE |
| K942222 | QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS | Isolab, Inc. | Jan 20, 1995 | SESE |
| K933086 | AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328 | Helena Laboratories | Oct 31, 1994 | SESE |
| K931234 | HEMOCARD CONTROL HB-AA, AE, FAA, FAE | Isolab, Inc. | May 11, 1993 | SESE |
| K924173 | HEMOCARD(TM) CONTROL | Isolab, Inc. | Dec 1, 1992 | SESE |
| K913427 | SICKLE HEMOGLOBIN (HBA/S) CONTROL SET | Creative Laboratory Products, Inc. | Nov 19, 1991 | SESE |
| K911347 | LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL | Bio-Rad | Jun 10, 1991 | SESE |
| K910431 | HEMOCARD CONTROL | Isolab, Inc. | Mar 11, 1991 | SESE |
| K820787 | HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL | Helena Laboratories | Apr 8, 1982 | SESE |
| K820037 | SICKLE-CHECK | Diagnostic Technology, Inc. | Feb 4, 1982 | SESE |
Top Applicants
- Isolab, Inc. — 4 clearances
- Helena Laboratories — 2 clearances
- Bio-Rad — 1 clearance
- Cantebury Scientific , Ltd. — 1 clearance
- Canterbury Health Laboratories — 1 clearance
