21 CFR 864.6550
Occult blood test
21 CFR 864.6550 is the regulation titled “Occult blood test” in 21 CFR Part 864, Hematology and Pathology Devices. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 803.17, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a medical device letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 12024
- 02025
- 02026
The regulation
Read the text of 21 CFR 864.6550 (eCFR, as of Sep 1, 2026)
(a) Identification. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)
(b) Classification. Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
[45 FR 60606, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 864.6550.
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1 letter cites both
- 21 CFR 807.3Definitions1 letter cites both
- 21 CFR 807.81When a premarket notification submission is required1 letter cites both
- 21 CFR 820.100Corrective and preventive action1 letter cites both
- 21 CFR 820.198Complaint files1 letter cites both
- 21 CFR 820.3Definitions1 letter cites both
- 21 CFR 820.30Design controls1 letter cites both
Latest letters citing it
The letter citing 21 CFR 864.6550 that FDA posted most recently.
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