Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1225](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1225) → SHB — Creatinine Test System For At Home Prescription Use

# SHB · Creatinine Test System For At Home Prescription Use

_Clinical Chemistry · 21 CFR 862.1225 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/SHB

## Overview

- **Product Code:** SHB
- **Device Name:** Creatinine Test System For At Home Prescription Use
- **Regulation:** [21 CFR 862.1225](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1225)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

## Classification Rationale

Class II.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K251281](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/SHB/K251281.md) | Nova Max Creat eGFR Monitoring System | Nova Biomedical Corporation | Jan 21, 2026 | SESE |

## Top Applicants

- Nova Biomedical Corporation — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/SHB](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/SHB)

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