Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7415](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7415) → JCM — Control, Hemoglobin, Abnormal

# JCM · Control, Hemoglobin, Abnormal

_Hematology · 21 CFR 864.7415 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JCM

## Overview

- **Product Code:** JCM
- **Device Name:** Control, Hemoglobin, Abnormal
- **Regulation:** [21 CFR 864.7415](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7415)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## 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](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JCM/K053031.md) | EXTENDSURE HBFASC CONTROL | Cantebury Scientific , Ltd. | Dec 7, 2005 | SESE |
| [K011389](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JCM/K011389.md) | HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) | Canterbury Health Laboratories | Jun 21, 2001 | SESE |
| [K983704](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JCM/K983704.md) | MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE | Roche Diagnostic Systems, Inc. | Feb 10, 1999 | SESE |
| [K942222](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JCM/K942222.md) | QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS | Isolab, Inc. | Jan 20, 1995 | SESE |
| [K933086](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JCM/K933086.md) | AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328 | Helena Laboratories | Oct 31, 1994 | SESE |
| [K931234](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JCM/K931234.md) | HEMOCARD CONTROL HB-AA, AE, FAA, FAE | Isolab, Inc. | May 11, 1993 | SESE |
| [K924173](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JCM/K924173.md) | HEMOCARD(TM) CONTROL | Isolab, Inc. | Dec 1, 1992 | SESE |
| [K913427](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JCM/K913427.md) | SICKLE HEMOGLOBIN (HBA/S) CONTROL SET | Creative Laboratory Products, Inc. | Nov 19, 1991 | SESE |
| [K911347](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JCM/K911347.md) | LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL | Bio-Rad | Jun 10, 1991 | SESE |
| [K910431](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JCM/K910431.md) | HEMOCARD CONTROL | Isolab, Inc. | Mar 11, 1991 | SESE |
| [K820787](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JCM/K820787.md) | HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL | Helena Laboratories | Apr 8, 1982 | SESE |
| [K820037](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JCM/K820037.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JCM](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JCM)

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