510(k) Report

510(k) · Cleared

Recalled · Class III · 2016

Sangui Biotech, Inc. Intact-PTH (Parathyroid Hormone) Elisa

K974306510(k) TraditionalCleared Dec 23, 199736-day reviewClass II21 CFR 862.1545Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sangui Biotech, Inc. · CEW Radioimmunoassay, Parathyroid Hormone

Cleared on Dec 23, 1997 after a 36-day review. The FDA summary names its predicate without a number. It has been recalled once.

Decided
Dec 23, 1997
Review
36 days
Class
Class II
Product code
CEW
Recalls
1
Predicates
0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K974306Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CEW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new CEW device

  1. #1 K231927 Elecsys PTH , Elecsys PTH STATscore 7.6 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*—Nichols Institute Diagnostics Allegro® Intact PTH (Parathyroid Hormone) kit
Named without a submission number
—
*—ACTIVE™ I-PTH ELISA kit
Named without a submission number
—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 26, 2016Class IIIZ-1520-2018Nonconforming Material/ComponentThere may be a loss of separation between Calibrators A and B which may impact the assay calibration at the lower end of the assay.

No ancestor or descendant has a Class I recall.

How does its category compare?

All CEW devices

CEW Radioimmunoassay, Parathyroid Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CEW

2in 2024

2007: 42010: 12012: 12013: 22014: 12015: 12017: 22019: 12023: 12024: 2
2007high 4 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CEW

160in 2007

2007: 160 days median
2007high 160 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CEW

1in 2025

2007: 12008: 12010: 32013: 12016: 22022: 22024: 22025: 1
2007high 3 (2010) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · CEW

37in 2025

2008: 82009: 42010: 232011: 972012: 1242013: 1722014: 1672015: 572016: 982017: 832018: 652019: 772020: 502021: 572022: 1882023: 822024: 672025: 37
2007high 188 (2022) · low 0 (2007)2025

MAUDE reports naming product code CEW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007416010
20080—18
20090—04
20101—323
20110—097
20121—0124
20132—1172
20141—0167
20151—057
20160—298
20172—083
20180—065
20191—077
20200—050
20210—057
20220—2188
20231—082
20242—267
20250—137
20260—0—

What is it indicated for?

The intended use of this product is the quantitative determination of Intact Parathyroid Hormone (PTH) in human serum. This immunoassay is based on the principles of the two site “sandwich” Enzyme-Linked ImmunoSorbent Assay (ELISA). The measurement of parathyroid hormone levels in the disease states is intended for the differential diagnosis of hypercalcemia and hypocalcemia resulting from the disorders of calcium metabolism.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Sangui Biotech, Inc.

5 FDA decisions under this applicant name. See the company

  • K001943Chronalco I.D.CDT (Carbohydrate Deficient Transferrin) AssaySangui Biotech, Inc. · 2000
  • K992799Sangui Biotech, Inc. Epo (Erythropoietin) Elisa KitSangui Biotech, Inc. · 2000
  • K982491Sangui Biotech, Inc. Calcitonin Elisa KitSangui Biotech, Inc. · 19981 recall
  • K982608Sangui Biotech, Inc. Acth (Adrenocorticotropic Hormone) Elisa KitSangui Biotech, Inc. · 1998

Recent decisions in CEW

The CEW category page

  • K231927Elecsys PTH , Elecsys PTH STATRoche Diagnostics · 2024
  • K232791Access Intact PTHBeckman Coulter, Inc. · 20241 recall
  • K221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackOrtho Clinical Diagnostics · 2023
  • K190702Lumipulse G whole PTHFujirebio Diagnostics,Inc. · 2019
  • K163658ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc. · 2017

https://510kreport.com/device/K974306 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974306: Sangui Biotech, Inc. Intact-PTH (Parathyroid Hormone) Elisa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974306

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026