Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7360](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7360) → JBF — Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening

# JBF · Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening

_Hematology · 21 CFR 864.7360 · Class 2_

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

## Overview

- **Product Code:** JBF
- **Device Name:** Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
- **Regulation:** [21 CFR 864.7360](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7360)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)
- **3rd-party reviewable:** yes

## Identification

An erythrocytic glucose-6-phosphate dehydrogenase assay is a device used to measure the activity of the enzyme glucose-6-phosphate dehydrogenase or of glucose-6-phosphate dehydrogenase isoenzymes. The results of this assay are used in the diagnosis and treatment of nonspherocytic congenital hemolytic anemia or drug-induced hemolytic anemia associated with a glucose-6-phosphate dehydrogenase deficiency. This generic device includes assays based on fluorescence, electrophoresis, methemoglobin reduction, catalase inhibition, and ultraviolet kinetics.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K201049](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBF/K201049.md) | FINDER G6PD | Baebies, Inc. | Sep 14, 2022 | SESE |
| [K161364](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBF/K161364.md) | BinaxNOW G6PD Test | Alere Scarborough, Inc. | Jun 17, 2016 | SESE |
| [K080003](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBF/K080003.md) | BINAXNOW G6PD TEST | Binax, Inc. | Oct 23, 2008 | SESE |
| [K024006](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBF/K024006.md) | G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE | Pointe Scientific, Inc., | Mar 31, 2003 | SESE |
| [K933934](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBF/K933934.md) | GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A | Sigma Diagnostics, Inc. | Jun 29, 1995 | SESE |

## Top Applicants

- Alere Scarborough, Inc. — 1 clearance
- Baebies, Inc. — 1 clearance
- Binax, Inc. — 1 clearance
- Pointe Scientific, Inc., — 1 clearance
- Sigma Diagnostics, Inc. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com