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K Number
K990684
Device Name
MODIFICATION OF SAS SERUM/URINE HCG
Manufacturer
SA SCIENTIFIC, INC.
Date Cleared
1999-05-10

(68 days)

Product Code
JHI
Regulation Number
862.1155
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

SASTM Serum/Urine hCG is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy. This test is for professional use only.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a diagnostic device. It does not contain any information about acceptance criteria or a study proving that the device meets those criteria.

The letter primarily:

  • Acknowledges receipt and review of the 510(k) notification (K990684).
  • Determines the device is substantially equivalent to legally marketed predicate devices.
  • Grants permission to market the device, subject to general controls and potential additional controls.
  • Provides contact information for CLIA categorization, labeling, and other regulatory matters.
  • Includes an "Indications for Use" statement for the device.

Therefore, I cannot provide the requested information. The document does not describe:

  1. A table of acceptance criteria or reported device performance.
  2. Sample sizes for test sets, data provenance, or study design.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication methods.
  5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
  6. Standalone performance studies.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 862.1155 Human chorionic gonadotropin (HCG) test system.

(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.