Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart J — Products Used In Establishments That Manufacture Blood and Blood Products](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products) → [21 CFR 864.9160](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9160) → KSX — Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use

# KSX · Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use

_Hematology · 21 CFR 864.9160 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSX

## Overview

- **Product Code:** KSX
- **Device Name:** Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use
- **Regulation:** [21 CFR 864.9160](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9160)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

Blood group substances of nonhuman origin for in vitro diagnostic use are materials, such as blood group specific substances prepared from nonhuman sources (e.g., pigs, cows, and horses) used to detect, identify, or neutralize antibodies to various human blood group antigens. This generic type of device does not include materials that are licensed by the Center for Biologics Evaluation and Research of the Food and Drug Administration.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K802534](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSX/K802534.md) | GAMMA PI BLOOD GROUP SUBSTANCE | Gamma Biologicals, Inc. | Nov 12, 1980 | SESE |
| [K802533](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSX/K802533.md) | GAMMA LEWIS BLOOD GROUP SUBSTANCE | Gamma Biologicals, Inc. | Nov 12, 1980 | SESE |
| [K800916](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSX/K800916.md) | P1 BLOOD GROUP SUBSTANCE | Travenol Laboratories, S.A. | May 8, 1980 | SESE |
| [K781896](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSX/K781896.md) | BLOOD GROUP SUBSTANCE A,B | North American Biologicals, Inc. | Dec 20, 1978 | SESE |
| [K781895](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSX/K781895.md) | BLOOD GROUP SUBSTANCE B | North American Biologicals, Inc. | Dec 20, 1978 | SESE |
| [K781862](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSX/K781862.md) | BLOOD GROUP SUBSTANCE A | North American Biologicals, Inc. | Dec 20, 1978 | SESE |
| [K771488](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSX/K771488.md) | P1 BLOOD GROUP SUBSTANCE | Ortho Diagnostics, Inc. | Nov 8, 1977 | SESE |
| [K771487](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSX/K771487.md) | LEWIS BLOOD GROUP SUBSTANCE | Ortho Diagnostics, Inc. | Nov 8, 1977 | SESE |

## Top Applicants

- North American Biologicals, Inc. — 3 clearances
- Gamma Biologicals, Inc. — 2 clearances
- Ortho Diagnostics, Inc. — 2 clearances
- Travenol Laboratories, S.A. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSX](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSX)

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