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 862.1470](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1470) → CFD — Sulfophosphovanillin, Colorimetry, Total Lipids

# CFD · Sulfophosphovanillin, Colorimetry, Total Lipids

_Clinical Chemistry · 21 CFR 862.1470 · Class 1_

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

## Overview

- **Product Code:** CFD
- **Device Name:** Sulfophosphovanillin, Colorimetry, Total Lipids
- **Regulation:** [21 CFR 862.1470](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1470)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A lipid (total) test system is a device intended to measure total lipids (fats or fat-like substances) in serum and plasma. Lipid (total) measurements are used in the diagnosis and treatment of various diseases involving lipid metabolism and atherosclerosis.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K863073](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFD/K863073.md) | TOTAL LIPIDS | J. D. Assoc. | Sep 9, 1986 | SESE |
| [K860112](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFD/K860112.md) | TOTAL LIPIDS REAGENT SET | Technostics Intl. | Jan 24, 1986 | SESE |
| [K820500](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFD/K820500.md) | TOTAL LIPID REAGENT SET | Anco Medical Reagents & Assoc. | Mar 11, 1982 | SESE |
| [K813469](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFD/K813469.md) | LIPID PROFILE | Bio-Analytics Laboratories, Inc. | Dec 31, 1981 | SESE |

## Top Applicants

- Anco Medical Reagents & Assoc. — 1 clearance
- Bio-Analytics Laboratories, Inc. — 1 clearance
- J. D. Assoc. — 1 clearance
- Technostics Intl. — 1 clearance

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

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